Senior Clinical Research Associate

Placements24; Stellenbosch; Hybrid; ZAR 520,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Medical and retirement provisions

Professional development opportunities

Hybrid work model

Career progression

Job summary

Placements24 is seeking an experienced Senior Clinical Research Associate to oversee site monitoring for our CRO client in Stellenbosch, Western Cape. The hybrid role combines remote oversight with essential on-site visits to investigator sites and our office.

You will ensure adherence to ICH-GCP, manage data quality, train site staff, and collaborate with cross-functional teams to advance clinical trials. Applicants should have at least four years as CRA and strong knowledge of CTMS and EDC

Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, or related field.
• Minimum of 4 years as a Clinical Research Associate with monitoring experience.
• In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
• Experience across multiple therapeutic areas is advantageous.
• Strong monitoring skills including SDV and query resolution.
• Proficiency with CTMS and EDC systems.
• Excellent organizational and communication abilities.
• Willingness to travel to clinical sites as required.
• Fluent in English, written and spoken.

Responsibilities

• Conduct pre-study, initiation, routine monitoring, and close-out visits at clinical trial sites.
• Ensure adherence to study protocols, SOPs, and regulatory requirements (ICH‑GCP).
• Verify accuracy and integrity of data through SDV.
• Manage site communication, training, and support to investigators and site staff.
• Monitor patient safety and report AEs/SAEs.
• Track study progress and address site-level issues and risks.
• Maintain TMF and site files.
• Collaborate with project managers, data managers, and medical monitors.
• Develop and review study documents (protocols, CRFs).
• Ensure timely enrollment and retention of subjects.

Skills

CTMS proficiency

EDC systems

Communication skills

Time management

Independent worker

Education

Bachelor’s degree in life sciences or related

Tools

CTMS software

EDC software

Job description

About the Role

Our client is a rapidly growing Contract Research Organization (CRO) dedicated to supporting the pharmaceutical and biotechnology industries in bringing life‑saving therapies to market. Based in the picturesque university town of Stellenbosch, Western Cape , we are looking for an experienced Senior Clinical Research Associate (CRA) to join our expanding clinical operations team. This pivotal role involves overseeing the conduct of clinical trials at investigator sites, ensuring compliance with protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. You will play a crucial part in monitoring trial progress, data quality, and subject safety. The ideal candidate will have a strong understanding of clinical trial processes, excellent monitoring skills, and a commitment to scientific integrity. This position offers a hybrid work arrangement, allowing for both remote work flexibility and essential on‑site visits to clinical sites and our office.

Key Responsibilities

• Conduct pre-study, initiation, routine monitoring, and close‑out visits at clinical trial sites.
• Ensure adherence to study protocols, Standard Operating Procedures (SOPs), and applicable regulatory requirements (e.g., ICH‑GCP).
• Verify the accuracy, completeness, and integrity of clinical data through source data verification (SDV).
• Manage site communication, providing training and support to investigators and site staff.
• Monitor patient safety and ensure timely reporting of adverse events (AEs) and serious adverse events (SAEs).
• Track study progress, identifying and resolving site‑level issues and risks.
• Maintain accurate and complete trial master files (TMF) and site files.
• Collaborate with internal teams, including project managers, data managers, and medical monitors.
• Contribute to the development and review of study‑related documents, such as protocols and case report forms (CRFs).
• Ensure timely enrollment and retention of subjects in assigned clinical trials.

Requirements

• Bachelor's degree in a life science, nursing, pharmacy, or a related discipline.
• Minimum of 4 years of experience as a Clinical Research Associate, with proven monitoring experience.
• In‑depth knowledge of ICH‑GCP guidelines and regulatory requirements for clinical trials.
• Experience with various therapeutic areas is advantageous.
• Excellent understanding of clinical trial processes from site initiation to close‑out.
• Strong monitoring skills, including source data verification and query resolution.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Exceptional organizational, time management, and communication skills.
• Ability to work independently, prioritize tasks, and manage a diverse workload.
• Willingness to travel to clinical sites as required for monitoring visits.
• Proficiency in English, both written and spoken.

Benefits

• Our client offers a competitive salary, a comprehensive benefits package including medical and retirement provisions, and performance‑based incentives.
• We provide extensive opportunities for professional development, including advanced training in clinical trial management and therapeutic areas.
• Our supportive work environment fosters collaboration and career progression.
• The hybrid model allows for a flexible approach to work, blending remote efficiency with vital on‑site engagement.
• Join our dedicated team in Stellenbosch and contribute to advancing medical research.