About the Role
Our client, a dynamic Contract Research Organization (CRO) focused on pharmaceutical clinical trials, is looking for a dedicated Pharmaceutical Clinical Research Associate (CRA) to join their team in Benoni, Gauteng. This hybrid role offers a balanced approach, combining essential on-site responsibilities with the flexibility of remote work. As a CRA, you will be instrumental in ensuring the successful execution of clinical trials, monitoring investigational sites, and verifying the accuracy and completeness of trial data. You will play a key role in bringing innovative new therapies to patients by adhering to protocols, Good Clinical Practice (GCP), and all applicable regulatory requirements. This position demands excellent organizational skills, strong attention to detail, and the ability to build rapport with investigators and site staff. The Benoni-based team works collaboratively, and this role provides a great opportunity for a clinically focused professional to advance their career in pharmaceutical research. The company is committed to the highest standards of ethical conduct and scientific integrity in all its research endeavors. Your contribution will directly impact the speed and success of drug development pipelines.
Key Responsibilities
- Conduct site initiation, routine monitoring, and close-out visits for assigned clinical trial sites.
- Verify the accuracy, completeness, and validity of clinical data by reviewing source documents and case report forms (CRFs).
- Ensure compliance with study protocols, Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP) guidelines.
- Manage and maintain trial master files (TMF) and other essential study documentation.
- Serve as the primary point of contact for investigators and site staff, providing training and support.
- Identify, track, and resolve site-level issues and deviations.
- Oversee drug accountability and ensure proper storage and handling of investigational medicinal products.
- Report study progress, risks, and issues to project management and study teams.
- Participate in site feasibility assessments and investigator selection.
- Ensure timely resolution of data queries and prompt reporting of adverse events.
- Contribute to the development of study-related documents, such as monitoring plans and site instructions.
Requirements
- Bachelor's degree in Nursing, Pharmacy, Life Sciences, or a related healthcare field.
- Minimum of 3-5 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical industry or CRO setting.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Proven experience in monitoring clinical trial sites and ensuring data integrity.
- Excellent understanding of medical terminology and clinical trial processes.
- Strong organizational and time management skills, with the ability to manage multiple sites and priorities.
- Excellent interpersonal and communication skills, with the ability to build strong relationships with site personnel.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to assigned clinical sites as required (approximately 50-60% travel).
- Must be able to fulfill on-site requirements in Benoni, Gauteng, as part of the hybrid model.
- Detail-oriented with a commitment to quality and accuracy.
Benefits
- Our client offers a competitive salary, commensurate with experience and qualifications.
- Comprehensive health and wellness benefits are provided, including medical aid and access to wellness programs.
- A provident fund is available with employer contributions.
- Generous annual leave and paid time off are granted.
- Opportunities for professional development, including ongoing training and certification support, are offered.
- The hybrid work arrangement provides flexibility and work-life balance.
- Our client is dedicated to fostering a collaborative and supportive work environment.
- Potential for performance-based incentives.
- Exposure to diverse therapeutic areas and innovative clinical trials.
- Career growth opportunities within a reputable CRO.
- Reimbursement for travel expenses incurred during site visits.