Senior Clinical Research Associate - Mossel Bay

Placements24; Mossel Bay; On-site; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Healthcare benefits

Retirement plan

Professional development

Job summary

Placements24 seeks a Senior Clinical Research Associate to oversee trial conduct in Mossel Bay, ensuring GCP compliance and patient safety. You will monitor sites, manage data integrity, and mentor junior CRAs, traveling extensively within the region.

You'll collaborate with investigators and staff, maintain regulatory files, and ensure timely reporting and QA across studies in a dynamic operations team.

Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy or related discipline.
• Minimum of 5 years as a Clinical Research Associate in pharma/biotech.
• Deep knowledge of ICH-GCP guidelines, trial processes and regulatory requirements.
• Proven experience monitoring sites and ensuring data integrity.
• Strong medical terminology knowledge applicable to current studies.
• Excellent written and verbal communication with strong interpersonal skills.
• Proficient in CTMS and EDC systems.
• Ability to work independently and meet strict deadlines.
• Willingness to travel extensively within the region.

Responsibilities

• Conduct site visits for selection, initiation, monitoring and close-out per protocol and GCP.
• Ensure accurate, timely data collection and source data verification.
• Protect the rights and safety of trial subjects.
• Verify data accuracy and traceability from source documents.
• Maintain relationships with investigators and site staff.
• Oversee study site regulatory files and documentation.
• Identify and report AEs/SAEs promptly.
• Troubleshoot issues and implement corrective actions.
• Ensure adherence to protocols and SOPs and regulatory guidelines.
• Prepare trip reports and track site progress and metrics.

Skills

Site monitoring

GCP knowledge

Data integrity

CTMS

EDC systems

Travel willingness

Mentorship

Education

Bachelor's degree in life sciences

Tools

CTMS

EDC

Job description

About the Role

Our client is seeking an experienced and highly dedicated Senior Clinical Research Associate (CRA) to join their expanding clinical operations team, based in or willing to relocate to Mossel Bay, Western Cape . This critical role will be responsible for overseeing the conduct of clinical trials, ensuring compliance with protocols, Good Clinical Practice (GCP), and all applicable regulatory requirements. The Senior CRA will play a key role in site selection, initiation, monitoring, and close-out activities, fostering strong relationships with investigators and site staff. This is a fantastic opportunity to contribute to the advancement of medical research and development in a beautiful coastal region, working on innovative therapeutic areas. We are looking for an individual with exceptional organizational skills, a meticulous eye for detail, and a strong commitment to patient safety and data integrity.

Key Responsibilities

• Conduct site visits (selection, initiation, interim monitoring, and close-out) in accordance with study-specific requirements and GCP guidelines.
• Ensure accurate, timely, and complete data collection by monitoring investigational sites.
• Verify that the rights and well-being of human subjects are protected.
• Confirm that the reported trial data are accurate, complete, and verifiable from source documents.
• Manage and maintain effective relationships with principal investigators and study site staff.
• Oversee the preparation, execution, and completion of study site regulatory files.
• Identify and report adverse events (AEs) and serious adverse events (SAEs) in a timely manner.
• Troubleshoot study-related issues at the site level and implement corrective actions.
• Ensure adherence to study protocols, company SOPs, and relevant regulatory guidelines.
• Prepare trip reports and track site progress and performance metrics.

Requirements

• A Bachelor's degree in a life science, nursing, pharmacy, or a related discipline.
• A minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical or biotechnology industry.
• In-depth knowledge of ICH-GCP guidelines, clinical trial processes, and regulatory requirements.
• Proven experience in monitoring clinical trial sites and managing data integrity.
• Strong understanding of medical terminology and disease areas relevant to current clinical research.
• Excellent written and verbal communication skills, with strong interpersonal and negotiation abilities.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to work independently, manage time effectively, and meet strict deadlines.
• Willingness to travel extensively within the assigned region to conduct site visits.
• Demonstrated ability to mentor junior CRAs or contribute to team leadership.

Benefits

Our client offers a competitive salary, excellent healthcare benefits including medical and dental coverage, and a retirement savings plan. Opportunities for professional growth, including specialized training and conference attendance, are provided. The working environment is collaborative and supportive, emphasizing work-life balance. This position is based in the scenic coastal town of Mossel Bay, Western Cape , offering a high quality of life.