Senior Clinical Research Associate (Pharmaceuticals)

Placements24; Benoni; On-site; ZAR 700,000 - 950,000; Full time

Benefits offered by this job

Health insurance

Bonuses and incentives

Paid time off

Professional development

Retirement savings plan

Car allowance

Job summary

Placements24 is seeking a Senior Clinical Research Associate to join our client’s clinical operations team in Benoni, Gauteng. You will oversee site monitoring, data verification, and regulatory compliance to ensure trials run to protocol and ICH-GCP standards.

The role requires a Bachelor's degree in life sciences, at least 5 years of CRA experience, and strong CTMS/EDC proficiency. You will travel to sites, mentor staff, and collaborate with investigators to deliver high-quality data.

Qualifications

• Bachelor's degree in life science, nursing, pharmacy, or related field.
• Minimum of 5 years of CRA experience in pharma/biotech.
• Strong knowledge of ICH-GCP guidelines and regulatory requirements.
• Proven site monitoring experience including all visit types.
• Excellent organizational and time management skills with ability to manage multiple priorities.
• Strong communication, interpersonal, and negotiation skills.
• Proficiency with CTMS and EDC systems.
• Ability to travel to clinical sites as required.
• Demonstrated ability to work independently and in a team in Benoni, Gauteng.
• Commitment to data quality and patient safety.

Responsibilities

• Perform site selection, initiation, interim monitoring, and close-out visits as per protocol and SOPs.
• Verify source documents against CRFs to ensure data integrity.
• Manage site timelines and deliverables, ensuring protocol adherence.
• Serve as primary contact for clinical sites and address inquiries.
• Ensure compliance with regulatory requirements, GCP, and study procedures.
• Train and mentor site staff on study procedures and data collection.
• Prepare site visit reports, follow-up letters, and essential study documentation.
• Contribute to study protocol development, informed consent forms, and documents.
• Identify and report potential protocol deviations or safety concerns to the PM.
• Manage study supplies and drug accountability at sites.

Skills

Site monitoring

ICh-GCP knowledge

CTMS/EDC proficiency

Time management

Communication

Independent work

Education

Bachelor's degree in life science or related

Tools

CTMS

EDC

Job description

About the Role

Our client, a leading biopharmaceutical company committed to advancing healthcare solutions, is seeking a dedicated and experienced Senior Clinical Research Associate (CRA) to join their esteemed clinical operations team in Benoni, Gauteng . This role is pivotal in ensuring the successful execution of clinical trials according to protocol, Good Clinical Practice (GCP), and regulatory requirements. As a Senior CRA, you will be responsible for site monitoring, data verification, and fostering strong relationships with investigators and site staff. You will play a critical role in bringing life-changing therapies to patients by upholding the highest standards of data integrity and patient safety. This position offers an exciting opportunity for a motivated professional to contribute to impactful clinical research within a supportive and dynamic environment in Benoni, Gauteng .

Key Responsibilities

• Perform site selection, initiation, interim monitoring, and close-out visits in accordance with study protocols and SOPs.
• Ensure the quality and integrity of data collected during clinical trials by verifying source documents against case report forms (CRFs).
• Manage study timelines and deliverables at the site level, ensuring adherence to protocol requirements.
• Act as the primary point of contact for clinical sites, addressing investigator queries and resolving issues promptly.
• Ensure compliance with all applicable regulatory requirements, GCP, and study-specific procedures.
• Train and mentor site staff on study procedures, data collection, and regulatory requirements.
• Prepare site visit reports, follow-up letters, and other essential study documentation.
• Contribute to the development and review of study protocols, informed consent forms, and other study documents.
• Identify and report any potential protocol deviations, adverse events, or safety concerns to the clinical project manager.
• Manage study supplies and drug accountability at clinical trial sites.

Requirements

• Bachelor's degree in a life science, nursing, pharmacy, or related field.
• Minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical or biotechnology industry.
• Thorough understanding of ICH-GCP guidelines and regulatory requirements for clinical trials.
• Proven experience in site monitoring, including conducting all types of site visits.
• Excellent organizational and time management skills, with the ability to manage multiple priorities effectively.
• Strong communication, interpersonal, and negotiation skills.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to clinical sites as required.
• Demonstrated ability to work independently and as part of a collaborative team in Benoni, Gauteng .
• Commitment to maintaining high standards of data quality and patient safety.

Benefits

• Competitive salary commensurate with experience and qualifications.
• Comprehensive health, dental, and vision insurance.
• Performance-based bonuses and incentives.
• Paid time off and company holidays.
• Opportunities for professional development and continued education.
• Retirement savings plan with company contributions.
• Car allowance and travel expenses reimbursed.
• A stimulating work environment contributing to the development of innovative medicines.