78 Clinical Research Associate jobs in South Africa
Clinical Research Associate
Posted 4 days ago
Job Viewed
Job Description
Job Title: Clinical Research Associate (CRA)
Location: Cape Town, South Africa
Company: ICON Strategic Solutions - FSP
As a Clinical Research Associate, your primary focus will be on the end-to-end management of clinical trials at assigned study sites. You will:
- Collaborate closely with the local study team to meet study goals, timelines, and site commitments.
- Serve as the primary point of contact for study sites, overseeing the preparation, initiation, monitoring, and closure of clinical trials.
- Ensure compliance with international guidelines (ICH-GCP) and local regulations to guarantee the integrity and safety of the study.
- Proactively identify and resolve study-related issues, escalating as necessary to ensure smooth site performance.
- Conduct monitoring visits (both on-site and remote) and manage essential study documentation.
- Assist in site training, patient recruitment, data management, and quality control to ensure the study runs efficiently.
- Maintain accurate and up-to-date records in CTMS and ensure study sites remain inspection-ready at all times.
We’re searching for a highly motivated individual with:
- A minimum of 3 years of experience as a CRA or in a similar role, preferably across multiple therapeutic areas.CV and Respiratory are an advantage.
- University degree in Health Science, or a related field .
- To be based in Cape Town.
- Compliance Knowledge: Strong knowledge of ICH-GCP guidelines and local regulatory requirements.
- Communication Skills: Excellent interpersonal and communication skills, with the ability to build strong relationships with investigators and site staff.
- Problem-Solving: A proactive approach to identifying and resolving issues while maintaining a high level of attention to detail.
- Adaptability: The ability to work effectively in a fast-paced and dynamic environment, managing multiple priorities with precision.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
#LI-SB1
#LI-Hybrid #J-18808-Ljbffr
Clinical Research Associate
Posted 6 days ago
Job Viewed
Job Description
Job Title: Clinical Research Associate (CRA) Location: Cape Town, South Africa
Company: ICON Strategic Solutions – FSP
ResponsibilitiesAs a Clinical Research Associate, your primary focus will be on the end-to-end management of clinical trials at assigned study sites. You will:
- Collaborate closely with the local study team to meet study goals, timelines, and site commitments.
- Serve as the primary point of contact for study sites, overseeing the preparation, initiation, monitoring, and closure of clinical trials.
- Ensure compliance with international guidelines (ICH-GCP) and local regulations to guarantee the integrity and safety of the study.
- Proactively identify and resolve study-related issues, escalating as necessary to ensure smooth site performance.
- Conduct monitoring visits (both on-site and remote) and manage essential study documentation.
- Assist in site training, patient recruitment, data management, and quality control to ensure the study runs efficiently.
- Maintain accurate and up-to-date records in CTMS and ensure study sites remain inspection-ready at all times.
We’re searching for a highly motivated individual with:
- A minimum of 3 years of experience as a CRA or in a similar role, preferably across multiple therapeutic areas.CV and Respiratory are an advantage.
- University degree in Health Science, or a related field.
- To be based in Cape Town.
- Compliance Knowledge: Strong knowledge of ICH-GCP guidelines and local regulatory requirements.
- Communication Skills: Excellent interpersonal and communication skills, with the ability to build strong relationships with investigators and site staff.
- Problem-Solving: A proactive approach to identifying and resolving issues while maintaining a high level of attention to detail.
- Adaptability: The ability to work effectively in a fast-paced and dynamic environment, managing multiple priorities with precision.
What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
#LI-SB1
#LI-Hybrid
#J-18808-LjbffrClinical Research Associate
Posted 6 days ago
Job Viewed
Job Description
Job Title: Clinical Research Associate (CRA)
Location: Cape Town, South Africa
Company: ICON Strategic Solutions – FSP
As a Clinical Research Associate, your primary focus will be on the end-to-end management of clinical trials at assigned study sites. You will:
- Collaborate closely with the local study team to meet study goals, timelines, and site commitments.
- Serve as the primary point of contact for study sites, overseeing the preparation, initiation, monitoring, and closure of clinical trials.
- Ensure compliance with international guidelines (ICH-GCP) and local regulations to guarantee the integrity and safety of the study.
- Proactively identify and resolve study-related issues, escalating as necessary to ensure smooth site performance.
- Conduct monitoring visits (both on-site and remote) and manage essential study documentation.
- Assist in site training, patient recruitment, data management, and quality control to ensure the study runs efficiently.
- Maintain accurate and up-to-date records in CTMS and ensure study sites remain inspection-ready at all times.
We’re searching for a highly motivated individual with:
- A minimum of 3 years of experience as a CRA or in a similar role, preferably across multiple therapeutic areas.CV and Respiratory are an advantage.
- University degree in Health Science, or a related field .
- To be based in Cape Town.
- Compliance Knowledge: Strong knowledge of ICH-GCP guidelines and local regulatory requirements.
- Communication Skills: Excellent interpersonal and communication skills, with the ability to build strong relationships with investigators and site staff.
- Problem-Solving: A proactive approach to identifying and resolving issues while maintaining a high level of attention to detail.
- Adaptability: The ability to work effectively in a fast-paced and dynamic environment, managing multiple priorities with precision.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
#LI-SB1
#LI-Hybrid
#J-18808-LjbffrClinical Research Associate
Posted 15 days ago
Job Viewed
Job Description
Our clinical activities are growing rapidly, and we are currently seeking full-time, home-based Clinical Research Associates to join our Clinical Monitoring team in South Africa. This position will work with a team to accomplish tasks and projects that are instrumental to the company’s success. The Clinical Research Associate at Medpace is offered the unique opportunity to be involved at every stage of the drug development process by providing unrivalled support to our customers. If you want an exciting career where you use your medical or health background and education, travel extensively and are instrumental in the clinical trials process, this could be the opportunity for you.
We kindly ask to submit applications in English.
Entry level associates with research associate or trial assistant-type backgrounds may also be considered.
Responsibilities- Conduct pre-study, initiation, monitoring, and closeout visits for research sites;
- Perform source document verification and case report form review;
- Perform regulatory document review;
- Conduct study drug inventory;
- Perform adverse event and serious adverse event reporting and follow-up;
- Assess patient recruitment and retention.
- Minimum a Bachelor of science in health-related field or equivalent
- Minimum of 1-year independent clinical monitoring; Entry level associates may be considered with relevant trial assistant or research associate-type backgrounds
- Broad knowledge of medical terminology and clinical patient management
- Basic knowledge of drug therapy techniques and clinical research methodologies
- Comprehensive knowledge of Local Regulations and ICH GCP
- Excellent oral and written communication skills
- Fluency in English
- Great attention to detail
- Must hold a valid driver’s license
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks
- Flexible work environment
- Competitive compensation and benefits package
- Competitive PTO packages
- Structured career paths with opportunities for professional growth
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
Awards
- Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
EO/AA Employer M/F/Disability/Vets
#J-18808-LjbffrClinical Research Associate
Posted today
Job Viewed
Job Description
Job Title: Clinical Research Associate (CRA)
Location: Cape Town, South Africa
Company: ICON Strategic Solutions – FSP
As a Clinical Research Associate, your primary focus will be on the end-to-end management of clinical trials at assigned study sites. You will:
- Collaborate closely with the local study team to meet study goals, timelines, and site commitments.
- Serve as the primary point of contact for study sites, overseeing the preparation, initiation, monitoring, and closure of clinical trials.
- Ensure compliance with international guidelines (ICH-GCP) and local regulations to guarantee the integrity and safety of the study.
- Proactively identify and resolve study-related issues, escalating as necessary to ensure smooth site performance.
- Conduct monitoring visits (both on-site and remote) and manage essential study documentation.
- Assist in site training, patient recruitment, data management, and quality control to ensure the study runs efficiently.
- Maintain accurate and up-to-date records in CTMS and ensure study sites remain inspection-ready at all times.
We’re searching for a highly motivated individual with:
- A minimum of 3 years of experience as a CRA or in a similar role, preferably across multiple therapeutic areas.CV and Respiratory are an advantage.
- University degree in Health Science, or a related field .
- To be based in Cape Town.
- Compliance Knowledge: Strong knowledge of ICH-GCP guidelines and local regulatory requirements.
- Communication Skills: Excellent interpersonal and communication skills, with the ability to build strong relationships with investigators and site staff.
- Problem-Solving: A proactive approach to identifying and resolving issues while maintaining a high level of attention to detail.
- Adaptability: The ability to work effectively in a fast-paced and dynamic environment, managing multiple priorities with precision.
What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
#LI-SB1
#LI-Hybrid
#J-18808-LjbffrClinical Research Associate
Posted today
Job Viewed
Job Description
Our clinical activities are growing rapidly, and we are currently seeking full-time, home-based Clinical Research Associates to join our Clinical Monitoring team in South Africa. This position will work with a team to accomplish tasks and projects that are instrumental to the company’s success. The Clinical Research Associate at Medpace is offered the unique opportunity to be involved at every stage of the drug development process by providing unrivalled support to our customers. If you want an exciting career where you use your medical or health background and education, travel extensively and are instrumental in the clinical trials process, this could be the opportunity for you.
We kindly ask to submit applications in English.
Entry level associates with research associate or trial assistant-type backgrounds may also be considered.
Responsibilities- Conduct pre-study, initiation, monitoring, and closeout visits for research sites;
- Perform source document verification and case report form review;
- Perform regulatory document review;
- Conduct study drug inventory;
- Perform adverse event and serious adverse event reporting and follow-up;
- Assess patient recruitment and retention.
- Minimum a Bachelor of science in health-related field or equivalent
- Minimum of 1-year independent clinical monitoring; Entry level associates may be considered with relevant trial assistant or research associate-type backgrounds
- Broad knowledge of medical terminology and clinical patient management
- Basic knowledge of drug therapy techniques and clinical research methodologies
- Comprehensive knowledge of Local Regulations and ICH GCP
- Excellent oral and written communication skills
- Fluency in English
- Great attention to detail
- Must hold a valid driver’s license
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks
- Flexible work environment
- Competitive compensation and benefits package
- Competitive PTO packages
- Structured career paths with opportunities for professional growth
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
Awards
- Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
EO/AA Employer M/F/Disability/Vets
#J-18808-LjbffrClinical Research Associate
Posted today
Job Viewed
Job Description
Job Title: Clinical Research Associate (CRA) Location: Cape Town, South Africa
Company: ICON Strategic Solutions – FSP
ResponsibilitiesAs a Clinical Research Associate, your primary focus will be on the end-to-end management of clinical trials at assigned study sites. You will:
- Collaborate closely with the local study team to meet study goals, timelines, and site commitments.
- Serve as the primary point of contact for study sites, overseeing the preparation, initiation, monitoring, and closure of clinical trials.
- Ensure compliance with international guidelines (ICH-GCP) and local regulations to guarantee the integrity and safety of the study.
- Proactively identify and resolve study-related issues, escalating as necessary to ensure smooth site performance.
- Conduct monitoring visits (both on-site and remote) and manage essential study documentation.
- Assist in site training, patient recruitment, data management, and quality control to ensure the study runs efficiently.
- Maintain accurate and up-to-date records in CTMS and ensure study sites remain inspection-ready at all times.
We’re searching for a highly motivated individual with:
- A minimum of 3 years of experience as a CRA or in a similar role, preferably across multiple therapeutic areas.CV and Respiratory are an advantage.
- University degree in Health Science, or a related field.
- To be based in Cape Town.
- Compliance Knowledge: Strong knowledge of ICH-GCP guidelines and local regulatory requirements.
- Communication Skills: Excellent interpersonal and communication skills, with the ability to build strong relationships with investigators and site staff.
- Problem-Solving: A proactive approach to identifying and resolving issues while maintaining a high level of attention to detail.
- Adaptability: The ability to work effectively in a fast-paced and dynamic environment, managing multiple priorities with precision.
What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
#LI-SB1
#LI-Hybrid
#J-18808-LjbffrBe The First To Know
About the latest Clinical research associate Jobs in South Africa !
Senior Clinical Research Associate, Cape Town based
Posted today
Job Viewed
Job Description
Job Overview
Perform monitoring and site management work for a variety of protocols, site and therapeutic areas.
Essential Functions
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
• Bachelor's Degree Degree in scientific discipline or health care preferred. Req
• Requires at least 3 years of year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Strong therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
#J-18808-LjbffrSenior Clinical Research Associate, Cape Town based
Posted 13 days ago
Job Viewed
Job Description
Perform monitoring and site management work for a variety of protocols, site and therapeutic areas.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Act as a mentor for clinical staff including conducting co-monitoring and training visits.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred. Req
- Requires at least 3 years of year of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Strong therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Contractor Clinical Research Associate - Diabetes and Obesity - South Africa - Remote
Posted 2 days ago
Job Viewed
Job Description
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.Join us!
At Worldwide Clinical Trials, we invite you to embark on a rewarding journey within Clinical Operations, where your contributions will leave a profound impact on the lives of patients.
As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases. Collaboration with top-tier colleagues from various backgrounds and specialties is not just encouraged; it's ingrained in our culture. Our commitment to advancing clinical research is nurtured within a supportive and team-oriented environment. In a CRA role, you'll receive extensive support through regulatory submissions, TMF management, and in-house CRAs for projects with heavy site management needs.
Through regular touchpoints and coaching conversations with your Line Manager, we ensure that your professional development remains a top priority. We offer a clear career path and development that can lead to Clinical Trial Manager roles. We take pride in our accessible Executive Leadership team, who are equally committed to advancing science and surmounting obstacles to make a difference in the lives of patients around the world.
We offer an unparalleled experience, where you can drive remarkable scientific breakthroughs and be at the very core of every successful clinical trial. Experience a world of difference with us at Worldwide!
What you will do
- Conduct all types of visits - site qualifications, initiation, interim monitoring, site management and study close-out visits
- Review study subject safety information and informed consent and conduct source document verification for compliance, patient safety, and veracity of data
- Actively participate in study team and investigator meetings
- Compile and ensure completeness of regulatory documents and ethical submission documentation and review study subject safety information and informed consent and study material (e.g. CRFs, manuals)
What you will bring to the role
- Excellent interpersonal, oral, and written communication skills in English and local language
- Superior organizational skills with attention to details, and the ability to work independently
- Broad understanding of clinical research principles and process
- Proficiency in Microsoft Office, CTMS and EDC Systems
Your experience
- At least two years independent clinical monitoring experience
- Demonstrable experience of handling multiple protocols across a range of therapeutic indications
- Four-year college curriculum in life sciences, OR Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree)
- Ability to meet the travel requirements of the job
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide !For more information on Worldwide, visit or connect with us on LinkedIn .
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative,innovative,and successful. We’reon a mission to hire thevery bestand are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. #J-18808-Ljbffr