Description
The Clinical Research Associate (CRA) will be responsible for initiation, monitoring and other tasks associated with clinical studies. The CRA will be responsible for investigational site management for clinical studies, and will assist in the creation and implementation of protocols, informed consents, case report forms, clinical study reports and related study materials. He/she will also provide guidance, clinical trial management and direction to contract CRAs in the field.Responsibilities:
- 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
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.