About the Role
Our client, a prominent global pharmaceutical company focused on developing groundbreaking treatments, is seeking a highly experienced Senior Clinical Research Associate (CRA) to contribute to their vital research initiatives in Randburg . This role is pivotal in overseeing and managing clinical trial sites, ensuring the integrity of data, and maintaining compliance with protocols and regulatory standards. The Senior CRA will act as a key liaison between the sponsor and investigational sites, providing expert guidance and support. This is an exceptional career opportunity for a seasoned professional looking to advance their career in clinical research within a company renowned for its commitment to scientific innovation and patient care.
Key Responsibilities
- Conduct site initiation, monitoring, and close-out visits for clinical trials in accordance with Good Clinical Practice (GCP) and protocol requirements.
- Verify the accuracy, completeness, and consistency of clinical data collected at investigational sites.
- Ensure adherence to study protocols, informed consent procedures, and all applicable regulatory requirements.
- Manage investigational product accountability and drug destruction at study sites.
- Act as the primary point of contact for clinical investigators and site staff, providing training and ongoing support.
- Identify, document, and resolve site-level issues and deviations in a timely manner.
- Prepare monitoring visit reports and follow up on action items with study sites.
- Contribute to the development of clinical trial protocols, case report forms (CRFs), and other study-related documents.
- Mentor and provide guidance to junior CRAs and study site personnel.
- Participate in team meetings and contribute to the overall success of clinical research projects.
Requirements
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- A minimum of 5-7 years of experience as a Clinical Research Associate in the pharmaceutical industry.
- Thorough understanding of GCP, ICH guidelines, and relevant regulatory requirements.
- Proven experience in monitoring clinical trial sites and managing data integrity.
- Excellent interpersonal, communication, and organizational skills.
- Strong ability to interpret clinical trial protocols and identify protocol deviations.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to investigational sites as required (up to 60%).
- Demonstrated ability to work independently and manage a diverse workload effectively.
Benefits
- Competitive salary package commensurate with experience.
- Performance-based bonuses and incentives.
- Comprehensive medical, dental, and vision coverage.
- Generous paid time off and company holidays.
- Retirement savings plan.
- Travel expenses fully reimbursed.
- Opportunities for professional development and career advancement.