Description
The Clinical Research Associate will:- Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual
- Co-ordinate and be responsible for the completion of study documentation materials such as CRFs, patient diaries, study participation cards and study reports
- Assist with protocol development and study report completion
- Monitor activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols
- Order and co-ordinate study supplies
- Negotiate contracts with vendors of clinical trial services
- Plan and participate in investigator meetings
- Assist and support data validation and clean file procedures
- Assure regulatory compliance of investigational sites FDA and ICH guidelines
Essential Requirements:
- Bachelor's degree in the life sciences or health-related field AND five or more years of related experience as a CRA and/or a licensed medical professional (such as RN or BSN) in a related clinical setting.
- Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations.
- Experience managing CROs and vendors.
- Demonstrated ability to work independently and on a team.
- Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook).
- Excellent oral and written communication skills, and strong organizational abilities.
- Oncology and/or neurology experience preferred.
- Travel required.