Senior Clinical Research Associate (CRA)

Placements24; Mossel Bay; Hybrid; ZAR 700,000 - 900,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Travel allowance

Professional development

Remote flexibility

Job summary

Placements24 is seeking a Senior Clinical Research Associate in Mossel Bay, Western Cape. You will monitor trials, ensure protocol adherence, and maintain data integrity across sites within Mossel Bay and surrounding areas.

The role requires 4–5 years as a CRA, strong ICH-GCP knowledge, and proficiency with EDC/CTMS. Travel up to 75% and a collaborative, professional team environment are offered.

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
• 4–5 years of CRA experience with strong trial conduct knowledge.
• In-depth knowledge of ICH-GCP and regulatory requirements.
• Proven experience in site monitoring including initiation, routine, and close-out visits.
• Excellent data management and analytical skills with attention to detail.

Responsibilities

• Conduct site initiation visits, routine monitoring visits and close-out visits.
• Ensure compliance with GCP, protocol, and regulatory standards.
• Verify data accuracy through source data verification and query resolution.
• Coordinate communication between trial sites, sponsors and CRO.
• Train and mentor site staff on study protocols and regulatory requirements.
• Identify and resolve site-level issues and discrepancies promptly.
• Monitor timelines and escalate risks to project management.
• Ensure timely submission of essential study documents and ISF maintenance.
• Contribute to development and review of study documents such as protocols and monitoring plans.
• Prepare monitoring visit reports and follow-up on action items.

Skills

GCP knowledge

Site monitoring

Data management

Communication

Travel readiness

EDC proficiency

CTMS proficiency

Education

Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related

Tools

EDC systems

CTMS

Job description

About the Role

Our client, a globally recognized contract research organization (CRO) committed to advancing medical science, is seeking a highly skilled and experienced Senior Clinical Research Associate (CRA) to join their team. This dynamic position is based in Mossel Bay, Western Cape, ZA, a scenic coastal town offering a unique work-life balance. The Senior CRA will be responsible for monitoring clinical trials, ensuring adherence to protocols, regulatory requirements, and data integrity. This is a prime opportunity to contribute to life-saving research and development within a supportive and professional environment. We are looking for a meticulous and dedicated professional to ensure the success of critical clinical studies at sites within the Mossel Bay, Western Cape, ZA region and beyond.

Key Responsibilities

• Conduct site initiation visits, routine monitoring visits, and close-out visits to clinical trial sites.
• Ensure compliance with Good Clinical Practice (GCP) guidelines, protocol requirements, and all applicable regulatory standards.
• Verify the accuracy, completeness, and consistency of clinical data through source document verification and query resolution.
• Manage communication between clinical trial sites, sponsors, and the CRO.
• Train and mentor site staff on study protocols, procedures, and regulatory requirements.
• Identify, track, and resolve site-level issues and discrepancies in a timely manner.
• Monitor site performance and adherence to timelines, escalating potential risks to project management.
• Ensure timely submission of essential study documents and maintenance of the investigator site file (ISF).
• Contribute to the development and review of study-related documents such as protocols, informed consent forms, and monitoring plans.
• Prepare comprehensive monitoring visit reports and follow up on action items.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
• Minimum of 4-5 years of experience as a Clinical Research Associate, with a strong understanding of clinical trial conduct.
• In-depth knowledge of ICH-GCP guidelines and relevant national/international regulations.
• Proven experience in site monitoring, including initiation, routine, and close-out visits.
• Excellent understanding of clinical trial processes, from site selection to study completion.
• Strong data management and analytical skills, with meticulous attention to detail.
• Exceptional interpersonal and communication skills, with the ability to build effective relationships with site personnel.
• Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Ability to work independently, manage time effectively, and travel frequently within the assigned territory (up to 75%).
• Strong problem-solving abilities and the capacity to handle challenging situations with professionalism.

Benefits

• Competitive annual salary: .
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with company contributions.
• Generous paid time off and travel allowance.
• Opportunities for professional development and certifications.
• Exposure to diverse and cutting-edge clinical trials.
• Work from a beautiful location in Mossel Bay, Western Cape, ZA, with remote flexibility for some tasks.
• Supportive and collaborative team environment.
• Annual performance-based incentives.