Senior Clinical Research Associate - Pharmaceutical

Placements24; Stellenbosch; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Medical aid

Retirement fund

Paid time off

Professional development opportunities

Bonuses

Job summary

Placements24 is seeking a highly experienced Senior Clinical Research Associate (CRA) to oversee and manage clinical trials from our Stellenbosch office in the Western Cape. The role combines on-site monitoring with remote flexibility, supporting protocol adherence and regulatory requirements.

You will monitor sites, ensure data integrity, train junior CRAs, and contribute to trial documentation and study lifecycles. A strong background in GCP/ICH and 5+ years in pharma is essential.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related healthcare discipline.
• Minimum 5 years of experience as a Clinical Research Associate in the pharmaceutical industry.
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
• Proven experience in monitoring clinical trials across various therapeutic areas.
• Demonstrated ability to conduct effective site initiation, monitoring, and close-out visits.
• Excellent organizational, time management, and problem-solving skills.
• Strong interpersonal and communication skills, with the ability to build rapport with diverse stakeholders.
• Proficiency in CTMS and EDC systems.
• Willingness to travel extensively to clinical sites as required.

Responsibilities

• Conduct site initiation visits, routine monitoring visits, and close-out visits at clinical trial sites.
• Ensure accurate and timely data collection, source document verification, and query resolution.
• Verify that study conduct is in compliance with the protocol, SOPs, Good Clinical Practice (GCP), and all applicable regulatory requirements.
• Build and maintain strong working relationships with investigators, site staff, and study sponsors.
• Identify and report potential protocol deviations, adverse events, and safety concerns in a timely manner.
• Manage investigational product accountability and ensure proper handling and storage.
• Train and mentor junior CRAs and site personnel on study-specific procedures.
• Contribute to the development of clinical trial protocols, case report forms (CRFs), and monitoring plans.
• Prepare monitoring visit reports and ensure effective communication with study teams.
• Participate in investigator meetings and provide essential site support throughout the study lifecycle.

Skills

GCP/ICH knowledge

Site monitoring

Travel-ready

Stakeholder communication

Education

Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related healthcare discipline

Tools

CTMS

EDC

Job description

About the Role Our client, a globally recognized pharmaceutical company, is actively recruiting for a highly experienced Senior Clinical Research Associate (CRA) to join their expanding clinical operations team. This vital role involves overseeing and managing clinical trials, ensuring adherence to protocols, regulatory requirements, and ethical standards. You will play a key part in the successful execution of studies aimed at bringing innovative therapies to market. The position is based in our client's well-established office in Stellenbosch, Western Cape, ZA, with a flexible hybrid working arrangement that blends on-site responsibilities with remote flexibility.

Key Responsibilities

• Conduct site initiation visits, routine monitoring visits, and close-out visits at clinical trial sites.
• Ensure accurate and timely data collection, source document verification, and query resolution.
• Verify that study conduct is in compliance with the protocol, SOPs, Good Clinical Practice (GCP), and all applicable regulatory requirements.
• Build and maintain strong working relationships with investigators, site staff, and study sponsors.
• Identify and report potential protocol deviations, adverse events, and safety concerns in a timely manner.
• Manage investigational product accountability and ensure proper handling and storage.
• Train and mentor junior CRAs and site personnel on study-specific procedures.
• Contribute to the development of clinical trial protocols, case report forms (CRFs), and monitoring plans.
• Prepare monitoring visit reports and ensure effective communication with study teams.
• Participate in investigator meetings and provide essential site support throughout the study lifecycle.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare discipline.
• Minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical industry.
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
• Proven experience in monitoring clinical trials across various therapeutic areas.
• Demonstrated ability to conduct effective site initiation, monitoring, and close-out visits.
• Excellent organizational, time management, and problem-solving skills.
• Strong interpersonal and communication skills, with the ability to build rapport with diverse stakeholders.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Willingness to travel extensively to clinical sites as required.
• Ability to work independently and manage a complex workload effectively.
• Experience with Phase I-IV clinical trials is preferred.

Benefits

• highly competitive salary
• performance-based bonuses
• medical aid
• retirement fund
• paid time off
• Employees benefit from ongoing professional development opportunities, including specialized training programs and support for maintaining certifications

This hybrid role offers a blend of remote flexibility and essential on-site engagement at our Stellenbosch, Western Cape, ZA location.

Join a collaborative and supportive team dedicated to advancing healthcare through innovative clinical research.

Career growth opportunities within a leading pharmaceutical organization are significant.