Clinical Research Associate - Pharmaceutical Trials

Placements24; South Africa; On-site; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Health insurance

Car allowance

Travel reimbursement

Training opportunities

Job summary

Placements24 is seeking a dedicated Clinical Research Associate (CRA) to oversee clinical trials in and around Tembisa. You will act as the primary liaison between the sponsor and investigative sites, ensuring data integrity, regulatory compliance, and patient safety.

The role requires site monitoring, GCP knowledge, and strong communication. Travel to sites in Gauteng region will be required, with opportunities for professional development within a supportive team.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related discipline.
• Minimum 3 years' CRA or similar clinical research experience in pharma/biotech.
• Thorough understanding of GCP, FDA regulations, and ICH guidelines.
• Experience monitoring sites and performing source data verification.
• Excellent communication, interpersonal, and organizational skills.

Responsibilities

• Conduct site selection, initiation, monitoring, and close-out visits for clinical trials according to protocol and regulatory requirements.
• Ensure adherence to Good Clinical Practice (GCP) guidelines, SOPs, and other applicable regulations.
• Verify the accuracy, completeness, and timeliness of study data through source data verification and query resolution.
• Train and support site staff on study procedures, protocol requirements, and regulatory compliance.
• Manage and maintain trial documentation, including Investigator Site Files (ISFs) and essential study documents.
• Report trial progress, site performance, and any identified issues or risks to the Clinical Trial Manager.

Skills

GCP knowledge

Site monitoring

Communication skills

Travel flexibility

Education

Bachelor's degree in Life Sciences/Nursing/Pharmacy or related

Job description

About the Role

Our client, a prominent player in the pharmaceutical industry , is seeking a dedicated Clinical Research Associate (CRA) to oversee clinical trials conducted in and around Tembisa . This role is crucial for ensuring the integrity, accuracy, and compliance of clinical trial data collected from study sites. You will serve as the primary liaison between the sponsor and the investigative sites, facilitating smooth trial operations and adherence to protocols. The ideal candidate possesses a keen eye for detail, a strong understanding of clinical trial processes, and a commitment to patient safety and data quality, contributing to the successful development of new therapies.

Key Responsibilities

• Conduct site selection, initiation, monitoring, and close-out visits for clinical trials according to protocol and regulatory requirements.
• Ensure adherence to Good Clinical Practice (GCP) guidelines, SOPs, and other applicable regulations.
• Verify the accuracy, completeness, and timeliness of study data through source data verification and query resolution.
• Train and support site staff on study procedures, protocol requirements, and regulatory compliance.
• Manage and maintain trial documentation, including Investigator Site Files (ISFs) and essential study documents.
• Report trial progress, site performance, and any identified issues or risks to the Clinical Trial Manager.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline.
• Minimum of 3 years of experience as a CRA or in a similar clinical research role within the pharmaceutical or biotech sector.
• Thorough understanding of GCP, FDA regulations, and ICH guidelines.
• Demonstrated experience in monitoring clinical trial sites and performing source data verification.
• Excellent communication, interpersonal, and organizational skills.
• Ability to travel to investigative sites within the designated region of Tembisa and surrounding areas as required.

Benefits

• Attractive annual salary commensurate with experience.
• Comprehensive health insurance plan and retirement savings options.
• Car allowance and travel expenses reimbursement for site visits.
• Professional development opportunities and ongoing training in clinical research methodologies.
• A supportive team environment dedicated to advancing medical research in Gauteng.