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.
Getinge AB 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.
