9 Research Studies jobs in South Africa

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

The main purpose of this position is to support the regulatory affairs activities conducted for the CTAC or other protocols as needed and to provide support to the unit with regards to overall management of all ethics and other regulatory matters. To co-ordinate clinical trials.

Responsibilities

Regulatory Administration (20%)

• Oversee and co-ordinate all local submissions to Ethics/Institutional review board (IRB) and other regulatory bodies.
• Act as interface between research team, sponsors, study coordinators (SCO’s) and universities to ensure complete and proper communication within projects and between all stakeholders.
• Manage the dissemination of information between all relevant stakeholders and IRBs.
• Monitor and review approvals to facilitate timeous renewal.
• Liaise with collaborators with regard to the preparation and submission of reports (including Serious Adverse Events (SAE) reports) to Human Research Ethics Committees (REC’s) / Institutional Review Boards (IRBs)

Coordination of Regulatory Affairs (20%)

• Lead the regulatory aspect of the study startup plan.
• Maintain and manage an efficient document filing and management system, including archiving procedures.
• Oversee the maintenance of investigator files with all essential documents.

Maintenance of Regulatory Documents (10%)

• Act as pivotal point of contact and develop regulatory affairs communication network for all collaborative sites.
• Ensure that investigator’s statutory and other documentation such as malpractice insurance and registration with Health Professionals Council of South Africa (HPCSA) (where applicable) is current and on file.
• Ensure accurate record keeping and timeous reporting to regulatory authorities.
• Provide consultation regarding ethics and regulatory issues.
• Advise regarding ongoing ethics GCP and GCLP training where appropriate.
• Oversee the import and exportation of vaccine and biological substances as it pertains to:
  • Obtaining relevant permits from various authorities.
  • Communicating and ensuring that permit conditions are met.

Study Coordination (50%)

• Ensure that protocols are reviewed, and adequate training of staff is maintained.
• Attend SIV, SAV and other investigator meetings/trainings as required.
• Attend monitors/audit visits as required.
• Ensure all study essential documentation is filed and up to date.
• Ensure all necessary approval for the study are obtained, and regulatory communications are maintained.
• Manage the recruitment and retention of study participants.
• Ensure that data entry is completed as per sponsor requirements.
• Ensure all adverse events are reported timeously.
• Ensure that the protocol, GCP and SOP guidelines are complied with at all times.
• Provide regular feedback to the study sponsor and principal investigator.
• Ensure that consenting, enrolment and follow up schedules are followed.
• Ensure that all study documentation is available, and progress reports are timeously submitted.

Qualifications

MINIMUM QUALIFICATIONS:

• Grade 12 and Tertiary degree or equivalent diploma in a related field.
• Professional registration/License as appropriate to qualification
• At least 5 years’ experience in working in the health and research sector.
• At least 2 years’ experience in a similar position dealing with regulatory and ethical issues.
• Experience and working knowledge of current enabling legislation as related to health and research.
• Experience and working knowledge of Good Clinical Practice and the Protection of Human Participants in Research.
• Experience and working knowledge of clinical trials.
• At least 5 years’ experience in clinical trials.

PREFERRED QUALIFICATIONS:

• Communication, teamwork, people management, clinical research and quality management experience
• Knowledge of South Africa Clinical Research Regulations
• Ability to work independently using own initiative
• Lateral, analytical and systematic thinking
• Ability to provide solutions to problems
• MS Office Skills
• Flexibility to adapt to changing job demands as the research unit evolves and develops
• GCP Standards
• Teamwork/collaboration
• Work management/Planning and organizing
• Problem solving/Analytical thinking
• Building interpersonal relationships
• People Management
• Quality commitment/Work standards
• Communication
• Client service and support
• Meeting facilitation/leadership, participation
• Research skills

Protection of Personal Information Act (POPIA) Consent to Use and Collection of Personal Information, Including Consent to Background Check.

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Job Summary

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.

Qualifications

• 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 Overview

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.

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Overview

The candidate will report to the Vice President of Research. Incumbent will manage all aspects of ongoing research studies. Attention to detail, self-starter, well organized, as well as good communication skills are essential. The applicant must adhere to patient confidentiality. The individual will be responsible for the oversight of studies conducted out of the clinical trials unit, including contracts, overseeing the research coordinators, study progress reports, orders, and other tasks as needed.

Responsibilities

• Monitor study metrics and site performance using standard study management tools.
• Oversee the individual study progress over the duration of each project.
• Act as the direct liaison between sponsors/investigators and the research coordinator or Vice President.
• Establish research data and workflow plans.
• Contribute to the development and implementation of SOPs, project-specific procedures, technical guidance documents, and patient acquisition plans.
• Direct the establishment of clinical and analytical study-related protocols and documents, as well as research/clinical data analysis.
• Manage the orders, sample deliveries, and supplies required for each study.
• Interface with investigational sites, clinical consultants, and labs.
• Manage research data sites and renewal terms related to each study and CTU functions.
• Direct all aspects of research data generation and analysis, including external site clinical studies and internal analytical studies.
• Drive internal communication, including timelines, budget, progress, and project needs for clinical trials to product teams and senior management.
• Interface with ORA, IRB, WMC, and other pharmaceutical/hospital research offices.

Qualifications

Education requirement: Bachelor's degree in biology, mathematics, computer science, natural sciences, or related areas.

Licenses or certifications: CITI certification.

Technical/Computer skills: Ability to use a combination of validated Electronic Data Capture (EDC) systems and/or other internal or commercial software tools and proven ability to learn and apply new software quickly as projects require. Familiarity with REDCap preferred. Strong IT skills, including excellent knowledge of various software programs and packages including MS Word, Excel, and Access.

Prior experience: Minimum of two years of related professional experience.

Skills:

• Ability to multi-task and meet established deadlines.
• Ability to work effectively both as part of a project team and independently.
• Excellent oral and written English communication skills.
• Proven experience using data management systems, tools, and processes to support multi-site, multimode research studies.
• Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to required guidelines, SOPs, and client expectations.
• Good organizational and analytical/problem-solving skills with strong attention to detail.
• Ability to work productively with minimal supervision.
• Ability to attain, maintain, and apply a working knowledge of GCPs and applicable SOPs.
• Strong customer focus and excellent interpersonal skills.

To qualify, applicants must be legally authorized to work in the United States and should not require now, or in the future, sponsorship for employment visa status.

Minimum Salary

USD $70,000.00/Yr.

Maximum Salary

USD $70,000.00/Yr.

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Overview The candidate will report to the Vice President of Research. Incumbent will manage all aspects of ongoing research studies. Attention to detail, self-starter, well organized, as well as good communication skills are essential. The applicant must adhere to patient confidentiality. The individual will be responsible for the oversight of studies conducted out of the clinical trials unit, including contracts, overseeing the research coordinators, study progress reports, orders, and other tasks as needed. Responsibilities Monitor study metrics and site performance using standard study management tools. Oversee the individual study progress over the duration of each project. Act as the direct liaison between sponsors/investigators and the research coordinator or Vice President. Establish research data and workflow plans. Contribute to the development and implementation of SOPs, project-specific procedures, technical guidance documents, and patient acquisition plans. Direct the establishment of clinical and analytical study-related protocols and documents, as well as research/clinical data analysis. Manage the orders, sample deliveries, and supplies required for each study. Interface with investigational sites, clinical consultants, and labs. Manage research data sites and renewal terms related to each study and CTU functions. Direct all aspects of research data generation and analysis, including external site clinical studies and internal analytical studies. Drive internal communication, including timelines, budget, progress, and project needs for clinical trials to product teams and senior management. Interface with ORA, IRB, WMC, and other pharmaceutical/hospital research offices. Qualifications Education requirement: Bachelor's degree in biology, mathematics, computer science, natural sciences, or related areas. Licenses or certifications: CITI certification. Technical/Computer skills: Ability to use a combination of validated Electronic Data Capture (EDC) systems and/or other internal or commercial software tools and proven ability to learn and apply new software quickly as projects require. Familiarity with REDCap preferred. Strong IT skills, including excellent knowledge of various software programs and packages including MS Word, Excel, and Access. Prior experience: Minimum of two years of related professional experience. Skills: Ability to multi-task and meet established deadlines. Ability to work effectively both as part of a project team and independently. Excellent oral and written English communication skills. Proven experience using data management systems, tools, and processes to support multi-site, multimode research studies. Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to required guidelines, SOPs, and client expectations. Good organizational and analytical/problem-solving skills with strong attention to detail. Ability to work productively with minimal supervision. Ability to attain, maintain, and apply a working knowledge of GCPs and applicable SOPs. Strong customer focus and excellent interpersonal skills. To qualify, applicants must be legally authorized to work in the United States and should not require now, or in the future, sponsorship for employment visa status. Minimum Salary USD $70,000.00/Yr. Maximum Salary USD $70,000.00/Yr. #J-18808-Ljbffr

Overview The candidate will report to the Vice President of Research. Incumbent will manage all aspects of ongoing research studies. Attention to detail, self-starter, well organized, as well as good communication skills are essential. The applicant must adhere to patient confidentiality. The individual will be responsible for the oversight of studies conducted out of the clinical trials unit, including contracts, overseeing the research coordinators, study progress reports, orders, and other tasks as needed. Responsibilities Monitor study metrics and site performance using standard study management tools. Oversee the individual study progress over the duration of each project. Act as the direct liaison between sponsors/investigators and the research coordinator or Vice President. Establish research data and workflow plans. Contribute to the development and implementation of SOPs, project-specific procedures, technical guidance documents, and patient acquisition plans. Direct the establishment of clinical and analytical study-related protocols and documents, as well as research/clinical data analysis. Manage the orders, sample deliveries, and supplies required for each study. Interface with investigational sites, clinical consultants, and labs. Manage research data sites and renewal terms related to each study and CTU functions. Direct all aspects of research data generation and analysis, including external site clinical studies and internal analytical studies. Drive internal communication, including timelines, budget, progress, and project needs for clinical trials to product teams and senior management. Interface with ORA, IRB, WMC, and other pharmaceutical/hospital research offices. Qualifications Education requirement: Bachelor's degree in biology, mathematics, computer science, natural sciences, or related areas. Licenses or certifications: CITI certification. Technical/Computer skills: Ability to use a combination of validated Electronic Data Capture (EDC) systems and/or other internal or commercial software tools and proven ability to learn and apply new software quickly as projects require. Familiarity with REDCap preferred. Strong IT skills, including excellent knowledge of various software programs and packages including MS Word, Excel, and Access. Prior experience: Minimum of two years of related professional experience. Skills: Ability to multi-task and meet established deadlines. Ability to work effectively both as part of a project team and independently. Excellent oral and written English communication skills. Proven experience using data management systems, tools, and processes to support multi-site, multimode research studies. Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to required guidelines, SOPs, and client expectations. Good organizational and analytical/problem-solving skills with strong attention to detail. Ability to work productively with minimal supervision. Ability to attain, maintain, and apply a working knowledge of GCPs and applicable SOPs. Strong customer focus and excellent interpersonal skills. To qualify, applicants must be legally authorized to work in the United States and should not require now, or in the future, sponsorship for employment visa status. Minimum Salary USD $70,000.00/Yr. Maximum Salary USD $70,000.00/Yr. #J-18808-Ljbffr

Job title : Senior Clinical Research Associate, Cape Town based Job Location : Western Cape, Cape Town Deadline : September 01, 2025 Quick Recommended Links Jobs by Location Job by industries Start Fragment 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 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 Power Point and use of a laptop computer and i Phone and i Pad (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. End Fragment Medical / Healthcare jobs #J-18808-Ljbffr

Sr Clinical Research Associate - Oncology/Haematology Experience

Sponsor Dedicated

Johannesburg based

Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• 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 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.
• 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 and Experience
• Bachelor's Degree Degree in scientific discipline or health care.

• Requires at least 3 years of on-site monitoring experience.

• Experience in Oncology/Haemotology required.

Knowledge and Skills

• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good therapeutic and protocol knowledge.
• 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

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**Sr Clinical Research Associate - Oncology/Haematology Experience**
**Sponsor Dedicated**
**Johannesburg based**
**Job Overview**
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
**Essential Functions**
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- 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 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.
- 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 and Experience**
- Bachelor's Degree Degree in scientific discipline or health care.
- Requires at least 3 years of on-site monitoring experience.
- Experience in Oncology/Haemotology required.
**Knowledge and Skills**
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge.
- 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.
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