Job Summary
The Sr. Clinical Research Associate plays a critical role in managing and overseeing clinical trials to ensure adherence to regulatory standards and protocols. This position demands a thorough understanding of clinical operations and the ability to collaborate effectively with diverse teams to facilitate the successful execution of clinical studies.
Responsibilities
- Monitor clinical trial sites to ensure compliance with the study protocol, regulatory requirements, and Good Clinical Practice (GCP).
- Conduct site selection, initiation, monitoring, and close-out visits for assigned studies.
- Maintain accurate and timely documentation of trial data and findings.
- Serve as a primary point of contact for site staff and coordinate communications between sites and the sponsor.
- Identify potential issues or risks related to clinical trials and develop action plans as necessary.
- Train and support site personnel to enhance compliance and quality of data collection.
- Collaborate with internal teams, including project management and data management, to ensure alignment on project goals.
Qualifications
- Bachelor’s degree in life sciences or a related field.
- A minimum of 3 years of experience in clinical research, preferably in a monitor role.
- Strong knowledge of clinical trial regulations and GCP guidelines.
- Excellent communication and interpersonal skills.
- Strong organizational skills and the ability to manage multiple projects simultaneously.
- Proficient in using clinical trial management systems and electronic data capture systems.
