About the Role
Our client is a leading pharmaceutical and biotechnology company at the forefront of dermatological innovation. We are seeking a highly experienced Senior Clinical Research Associate (CRA) with a specialized focus on dermatology to join our dynamic team. This is a fully remote position, offering the flexibility to work from anywhere within South Africa, though proximity to Randburg, Gauteng, ZA , for occasional site visits or team meetings may be advantageous. The Senior CRA will be instrumental in overseeing and managing clinical trials for novel dermatological treatments, ensuring adherence to protocols, regulations, and ethical standards. You will be responsible for site selection, initiation, monitoring, and closure, working closely with investigators, study coordinators, and internal teams. If you possess a strong background in clinical research, a deep understanding of dermatology, and a commitment to advancing medical science, this role offers a challenging and rewarding career path.
Key Responsibilities
- Plan, implement, and manage clinical trial activities according to study protocols, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements.
- Conduct site selection, qualification, initiation, interim monitoring, and close-out visits to ensure compliance and data integrity.
- Verify the accuracy, completeness, and validity of clinical trial data by reviewing source documents and case report forms (CRFs).
- Ensure that investigational products are managed correctly at clinical sites, adhering to storage and dispensing requirements.
- Monitor subject safety and ensure all adverse events (AEs) and serious adverse events (SAEs) are reported promptly and accurately.
- Build and maintain strong working relationships with investigators, site staff, and internal study teams.
- Prepare and present study progress reports to management and relevant stakeholders.
- Assist in the development of study-related documents, including protocols, informed consent forms, and monitoring plans.
- Identify and elevate potential study risks and issues, proposing and implementing appropriate solutions.
- Ensure compliance with all company policies and procedures related to clinical research.
Requirements
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
- A Master's degree or equivalent advanced degree is a plus.
- A minimum of 5 years of experience as a Clinical Research Associate, with a significant portion focused on dermatology or a related therapeutic area.
- In-depth knowledge of GCP, ICH guidelines, and other relevant regulatory requirements (e.g., FDA, EMA).
- Proven experience in monitoring clinical trials, including site visits, data review, and regulatory compliance checks.
- Familiarity with dermatology-specific clinical endpoints, assessment scales, and patient populations.
- Excellent understanding of clinical trial processes from site selection through to study closure.
- Strong analytical, problem‑solving, and critical‑thinking skills.
- Exceptional communication, negotiation, and interpersonal skills.
- Ability to work independently with minimal supervision and manage a remote workload effectively.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
Benefits
- Highly competitive salary and comprehensive benefits package, including medical, dental, and retirement plans.
- Generous paid time off and flexible work arrangements.
- Opportunities for international travel for site visits and conferences.
- Professional development opportunities and support for continuing education.
- Be part of groundbreaking research that improves patient lives.
- A collaborative and supportive remote work culture.
- Access to cutting‑edge research and development resources.