Job Summary
We are seeking a dedicated Senior Clinical Research Associate to join our enthusiastic team in Overland Park, Kansas. In this key role, you will be instrumental in overseeing and managing clinical trial sites, ensuring adherence to regulatory standards and maintaining essential documentation such as the Trial Master File (TMF) and Investigator’s Site File (ISF) according to GCP/ICH guidelines as well as local regulations.
Responsibilities
- Conduct monitoring visits to ensure compliance with regulatory requirements.
- Oversee the proper documentation and filing of essential trial materials.
- Collaborate with internal teams and external stakeholders to facilitate the smooth progression of clinical trials.
- Assist in the regulatory submission process and site initiation activities.
- Ensure the integrity of data collected and report any discrepancies or issues.
Qualifications
- Bachelor’s degree in a related field or equivalent experience.
- Proven experience as a Clinical Research Associate, preferably in oncology.
- Strong knowledge of GCP/ICH guidelines and regulatory standards.
- Excellent organizational and communication skills.
- Ability to work effectively in a team and manage multiple priorities.
