Clinical Research Associate II

About the Role Our client, a rapidly growing pharmaceutical company, is looking for an experienced Clinical Research Associate II (CRA II) to join their dedicated clinical operations team. This role is crucial for ensuring the successful execution of clinical trials according to regulatory standards and protocols. The CRA II will be responsible for monitoring clinical trial sites, ensuring data integrity, and fostering strong relationships with investigators and site staff. This is an excellent opportunity to advance your career in clinical research within a supportive and innovative environment located in Tembisa, Gauteng. We are committed to developing life-changing therapies, and our CRAs are at the forefront of this mission, contributing directly to patient safety and data accuracy.

Key Responsibilities

• Conduct site selection, initiation, monitoring, and close-out visits in accordance with Good Clinical Practice (GCP) guidelines.
• Ensure that clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and applicable regulatory requirements.
• Verify the accuracy, completeness, and integrity of clinical data by reviewing source documents and case report forms (CRFs).
• Manage and maintain trial master files (TMF) and other essential study documents.
• Communicate effectively with investigators, site staff, and internal project teams regarding study progress and site performance.
• Identify, track, and resolve site issues and deviations in a timely manner.
• Ensure subject safety and protocol compliance at all assigned clinical sites.
• Prepare and present monitoring visit reports and action items.
• Participate in investigator meetings and training sessions.

Requirements

• Bachelor's degree in a life science, nursing, or related discipline.
• Minimum of 3-5 years of experience as a Clinical Research Associate, with demonstrated experience in monitoring clinical trials.
• In-depth knowledge of GCP, ICH guidelines, and relevant pharmaceutical regulations.
• Proven experience in conducting site monitoring visits and managing CRFs and TMFs.
• Excellent organizational and time management skills.
• Strong written and verbal communication skills.
• Ability to travel to clinical trial sites as required (up to 60%).
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Demonstrated ability to work independently and as part of a team.
• Attention to detail and commitment to data quality and patient safety.

Benefits

• Our client offers a competitive compensation package, including a comprehensive health insurance plan, life insurance, a retirement fund contribution, and paid time off.
• Opportunities for professional development, including ongoing training and certifications, are readily available.
• Employees also benefit from a positive work culture that prioritizes work-life balance and team collaboration.
• This role is based in Tembisa, Gauteng, offering a chance to work with a dedicated team and contribute to significant advancements in medical treatment.

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