Job Summary
The Clinical Research Associate (CRA) plays a vital role in the clinical trial process, ensuring that studies are conducted in compliance with regulatory standards and that data is gathered accurately to support medical research. CRAs act as vital links between the sponsor and the various stakeholders, including investigative sites and clinical teams, to facilitate the successful execution of clinical studies.
Responsibilities
- Conduct on-site monitoring visits to collect data, verify its accuracy, and ensure adherence to Good Clinical Practice (GCP) guidelines.
- Assist in the preparation and management of study documentation, including protocols and informed consent forms.
- Assess and report compliance deviations and work with investigational sites to resolve any issues.
- Coordinate with study teams to ensure trial milestones are achieved and timelines are met.
- Maintain detailed records of monitoring activities, including site visit reports and correspondence.
- Participate in clinical trial team meetings and contribute to strategy discussions to improve trial execution.
Qualifications
- Bachelor’s degree in a life sciences field or a related discipline.
- Prior experience in clinical research, preferably as a CRA or in a related role.
- In-depth knowledge of GCP, regulatory guidelines, and clinical trial processes.
- Excellent communication and interpersonal skills to interact with diverse groups.
- Strong analytical and organizational abilities to manage multiple tasks efficiently.
- Proficient in using clinical trial management systems and Microsoft Office Suite.
Mass General Brigham provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
