Job Summary
The Clinical Research Associate II, Phase I, plays an essential role in the execution and management of clinical trials, focusing specifically on Phase I studies. This position requires an individual who is well-versed in clinical research processes and regulations, ensuring that studies are conducted in compliance with established protocols and regulatory guidelines. The successful candidate will contribute to the advancement of clinical trials through vigorous monitoring and effective communication with study sites.
Responsibilities
- Oversee the initiation, monitoring, and closure of Phase I clinical trials.
- Ensure compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
- Conduct site visits to assess study progress and address any issues that arise.
- Document and report findings, including tracking of site performance and data quality.
- Collaborate with internal teams and provide updates on study status and milestones.
- Facilitate training sessions for site staff regarding protocol and study procedures.
- Support the resolution of queries and discrepancies related to clinical data.
Qualifications
- Bachelor’s degree in a relevant scientific discipline or equivalent experience.
- Previous experience as a Clinical Research Associate, particularly with Phase I studies.
- Strong knowledge of clinical research guidelines and regulations.
- Excellent communication and interpersonal skills, with proficiency in report writing.
- Ability to work independently and manage multiple tasks within tight deadlines.
- Proficient in using clinical trial management software and Microsoft Office Suite.
