Job Summary
The Senior Clinical Research Associate (CRA) plays a crucial role in overseeing and managing clinical trials. This position ensures that studies are conducted in compliance with regulatory guidelines and maintains high standards of data integrity and patient safety. The Senior CRA collaborates with various stakeholders, including clinical teams, to facilitate successful trial execution.
Responsibilities
- Oversee site management activities, ensuring adherence to protocols and regulatory requirements.
- Coordinate the implementation of clinical trial protocols and monitor site performance.
- Conduct site visits to assess compliance and overall study progress.
- Maintain detailed records and prepare study-related documentation as required.
- Assist in training and mentoring junior CRAs and other team members.
- Act as a primary point of contact for investigators, answering queries and providing necessary support.
- Manage problem-solving efforts and escalate issues to the project management team as necessary.
- Ensure the accurate collection and reporting of study data, supervising data entry processes.
Qualifications
- Bachelor’s degree in Life Sciences or a related field.
- A minimum of 3 years of experience in clinical research, preferably with a focus on monitoring.
- Proficient understanding of GCP, FDA regulations, and ICH guidelines.
- Strong organizational and interpersonal skills, with a detail-oriented approach.
- Ability to work independently and as part of a collaborative team.
- Effective communication skills, both verbal and written.
- Proficiency in using clinical trial management systems and relevant software.
