Job Summary
The Senior Clinical Research Associate (CRA) will play an essential role in managing and overseeing clinical trials specifically within the cardio metabolic domain. This position requires expertise in ensuring compliance with regulatory standards and maintaining the integrity of study data. The CRA will work closely with clinical sites, coordinating the execution of clinical studies and monitoring their progress within the US Central region.
Responsibilities
- Manage the conduct of clinical trials in accordance with protocols, regulatory requirements, and company policies.
- Conduct site assessments and selection to ensure suitability for clinical studies.
- Maintain consistent communication with clinical sites to monitor study status and address any issues.
- Review and verify the accuracy of data collected from clinical sites.
- Collaborate with cross-functional teams to optimize study execution and ensure timely delivery of study milestones.
- Provide training and support to site staff on study protocols and procedures.
- Prepare and submit necessary reports as per regulatory guidelines.
Qualifications
- Bachelor’s degree in a health-related field or equivalent experience.
- Proven experience in clinical research, particularly in cardio metabolic studies.
- Strong understanding of Good Clinical Practice (GCP) and regulatory requirements.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Proficient in using clinical trial management software and Microsoft Office Suite.
