About the Role
Our client, a leading global pharmaceutical company engaged in groundbreaking research within the beauty and wellness sector, is seeking a dedicated Clinical Research Associate (CRA) with a specialization in dermatology. This role requires on-site fieldwork to manage and monitor clinical trials for innovative dermatological treatments and cosmetic products across various sites, particularly within the Bloemfontein region. You will be responsible for ensuring the quality, integrity, and compliance of clinical trials by adhering to strict protocols and regulatory guidelines. The ideal candidate will possess a strong scientific background, meticulous attention to detail, and excellent interpersonal skills to effectively liaise with investigators, site staff, and internal project teams. This position is crucial for advancing the development of new dermo-cosmetic solutions.
Key Responsibilities
- Conduct site initiation visits, routine monitoring visits, and site closure visits according to the Clinical Monitoring Plan.
- Verify the accuracy and completeness of clinical data by reviewing source documents and case report forms (CRFs).
- Ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements.
- Manage investigational product accountability and ensure proper storage and handling at clinical sites.
- Train site staff on study procedures, protocols, and regulatory requirements.
- Serve as the primary point of contact for assigned clinical sites in Bloemfontein and surrounding areas.
- Identify, resolve, or escalation site-related issues and risks in a timely manner.
- Prepare and submit monitoring visit reports, follow-up letters, and other required documentation.
- Participate in study team meetings and contribute to the overall success of the clinical trial.
- Maintain effective communication with investigators, clinical research coordinators, and other site personnel throughout the trial lifecycle.
Requirements
- Bachelor's degree in a life science, nursing, pharmacy, or a related scientific discipline.
- Minimum of 3-5 years of experience as a Clinical Research Associate, with demonstrated experience in dermatology or cosmetic clinical trials.
- Thorough understanding of ICH-GCP guidelines and other relevant regulatory requirements.
- Proven ability to conduct site monitoring activities and manage data integrity.
- Excellent communication, interpersonal, and organizational skills.
- Ability to travel frequently to clinical sites within the Free State province and potentially beyond.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Strong problem-solving skills and the ability to work independently and as part of a team.
- Valid driver's license and willingness to undertake site visits as required.
- Familiarity with the healthcare landscape in Bloemfontein is advantageous.
Benefits
- Competitive salary package.
- Company car and travel allowances.
- Comprehensive health, dental, and vision insurance.
- Opportunities for professional development and career advancement within a global organization.
- Exposure to cutting-edge research in a growing sector.
- Contribute to impactful dermatological advancements for the Bloemfontein community.