4 Senior Clinical Research Associate Pharmaceutical Development jobs in Placements24

• Oversee and manage all aspects of clinical trial conduct from site initiation to closeout.
• Ensure compliance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and other relevant regulatory requirements.
• Select, train, and monitor clinical trial sites and investigators to ensure data integrity and patient safety.
• Develop and maintain strong relationships with investigators, site staff, and study sponsors.
• Prepare for and participate in site audits and regulatory inspections.
• Manage study timelines, budgets, and resources effectively.
• Review and ensure the accuracy and completeness of clinical data, source documents, and case report forms (CRFs).
• Identify and report adverse events and serious adverse events promptly.
• Contribute to the development of clinical trial protocols, informed consent forms, and other study-related documents.
• Prepare comprehensive study reports and regulatory submission documents.

• Bachelor's degree in a life science, nursing, pharmacy, or related discipline. A Master's degree or higher is a plus.
• Minimum of 5-7 years of progressive experience in clinical research, with a significant portion in a CRA role.
• In-depth knowledge of GCP, ICH guidelines, FDA regulations, and other relevant pharmaceutical regulations.
• Proven experience in managing multiple clinical trial sites simultaneously.
• Excellent understanding of medical terminology, disease processes, and clinical trial procedures.
• Strong analytical, problem-solving, and critical thinking skills.
• Exceptional communication, interpersonal, and negotiation skills.
• Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and standard office software.
• Demonstrated ability to work independently and manage time effectively in a remote setting.
• Willingness to travel as needed for site visits (post-pandemic or as required by specific projects).

• Competitive annual salary commensurate with experience.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and company holidays.
• Retirement savings plan with company matching.
• Professional development opportunities and continuous learning support.
• Home office stipend to ensure a productive remote work environment.
• Access to state-of-the-art virtual collaboration tools and platforms.
• Opportunity to work on groundbreaking pharmaceutical projects impacting patient lives.

Our client, a leading innovator in the pharmaceutical industry, is seeking a highly experienced and motivated Senior Clinical Research Associate (CRA) to join their dynamic team in Johannesburg, Gauteng . This is an exceptional opportunity to contribute to cutting-edge drug development projects, working within a collaborative environment that fosters professional growth and scientific advancement. The Senior CRA will play a crucial role in ensuring the successful execution of clinical trials, adhering to the highest standards of quality, ethics, and regulatory compliance. You will be instrumental in bridging the gap between research and patient care, driving the development of life-saving therapies. This role demands a meticulous approach, strong analytical skills, and a passion for making a tangible difference in healthcare. The ideal candidate will possess a deep understanding of clinical trial processes, from site initiation to close-out, and excel in managing multiple priorities.

• Oversee and manage clinical trial sites in accordance with Good Clinical Practice (GCP) guidelines and company SOPs.
• Conduct site initiation, monitoring, and close-out visits to ensure protocol adherence, data integrity, and patient safety.
• Serve as the primary point of contact for study sites, building strong relationships with investigators and site staff.
• Ensure timely and accurate data collection, review, and query resolution.
• Monitor study progress, identify potential risks, and implement mitigation strategies.
• Prepare monitoring reports and provide regular updates to the project management team.
• Ensure compliance with all relevant regulatory requirements, including local and international regulations.
• Assist in the training and mentorship of junior CRAs.
• Contribute to the development and review of study-related documents, such as protocols and case report forms.

• Bachelor's degree in a life science, nursing, or a related field. A Master's degree is preferred.
• Minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical industry.
• In-depth knowledge of ICH-GCP guidelines and local regulatory requirements in South Africa .
• Proven experience in monitoring various phases of clinical trials.
• Excellent communication, interpersonal, and problem-solving skills.
• Strong organizational and time management abilities, with a proven track record of managing multiple projects simultaneously.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to study sites as required (approximately 50-60% travel).
• Fluency in English, with strong written and verbal communication skills.

Our client offers a competitive remuneration package, including a performance-based bonus structure. You will benefit from comprehensive health insurance, a generous retirement fund contribution, and ongoing professional development opportunities. Enjoy a supportive and collaborative work environment with access to the latest technologies and research advancements. This role provides a clear career progression path within a globally recognized pharmaceutical organization. Be part of a team dedicated to improving global health outcomes from our base in Johannesburg .

• Plan, initiate, monitor, and close-out clinical trial sites, ensuring compliance with Good Clinical Practice (GCP) and all applicable regulations.
• Conduct site visits (routine monitoring, initiation, and close-out) to assess protocol adherence, data integrity, and subject safety.
• Train and mentor junior CRAs and site staff on study protocols, procedures, and regulatory requirements.
• Develop and maintain strong working relationships with investigators, site staff, and internal project teams.
• Review and reconcile clinical data, identify discrepancies, and ensure timely resolution.
• Prepare and present study progress reports to project management and other stakeholders.
• Manage site-level budgets and timelines effectively.
• Ensure accurate and timely completion of source documents and case report forms (CRFs).
• Participate in the development of study-related documents, including protocols, informed consent forms, and investigator brochures.

• Bachelor's degree in a life science, nursing, or a related scientific field. Advanced degree (Masters or PhD) preferred.
• Minimum of 5 years of direct experience as a Clinical Research Associate in the pharmaceutical industry.
• Demonstrated knowledge of ICH-GCP guidelines and regulatory requirements in South Africa and globally.
• Proven experience in managing multiple clinical trials simultaneously across various therapeutic areas.
• Excellent understanding of clinical trial operations, drug development processes, and pharmaceutical research.
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Exceptional organizational and time management abilities.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Excellent written and verbal communication skills in English.
• Willingness to travel up to 60% of the time within **Johannesburg** and surrounding areas as required.

• Competitive annual salary package.
• Comprehensive medical and retirement benefits.
• Opportunities for professional development and career advancement.
• Generous paid time off and sick leave.
• Access to state-of-the-art research facilities.
• A collaborative and supportive work environment in **Johannesburg** contributing to impactful medical advancements.