Job Summary
The Clinical Research Associate II plays a pivotal role in managing and overseeing clinical trials. This position requires thorough knowledge of regulatory requirements and an understanding of the clinical research process to ensure that all activities are compliant and that data integrity is maintained. The ideal candidate should be adept at working collaboratively with various stakeholders and possesses strong problem-solving skills.
Responsibilities
- Oversee the conduct of clinical trials to ensure compliance with protocols and regulatory guidelines.
- Monitor study sites to confirm proper data collection and adherence to Good Clinical Practice (GCP).
- Communicate effectively with investigators and site staff to facilitate study milestones.
- Review and verify trial-related documents to ensure accuracy and completeness.
- Assist in the training of new staff and provide ongoing support to study personnel.
- Prepare and maintain study reports and documentation necessary for regulatory submissions.
Qualifications
- BA/BS degree in life sciences, nursing, or related field.
- Minimum of 2 years experience in clinical research or a related environment.
- Solid understanding of clinical trial phases and GCP guidelines.
- Strong organizational and time management skills with the ability to manage multiple studies.
- Excellent written and verbal communication abilities.
- Proficiency in clinical trial management systems and data analysis software.
