Summary of the position:
The Clinical Research Associate (CRA) monitors clinical study site activities to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols.
Reviews regulatory documents as required and prepares site visit reports. Maybe responsible for multiple projects and must work both independently and in a team environment. Participate in the study development and start-up process including reviewing protocols, designing and/or reviewing Case Report Forms (CRF), preparing Informed Consent Forms (ICF’s), developing study documents, organizing and presenting at investigator meetings, working with management on a monitoring strategy, and/or developing project-specific CRA training. S/he may participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. S/he may provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Prepares clinical documents, business correspondence, and procedural manuals. Maintain systems and process necessary to report trial status and activities; and to help ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget. Depending upon the level of experience, may become involved, when required, in other areas of study management and staff training. Contributes to the review of sponsor/client’s and/or FHI Clinical’s systems and procedures as appropriate.
Knowledge, skills and abilities:
Expected travel time is greater than 25% for this position. (default is less than 10%)
Note: Never pay for any training, certificate, assessment, or testing to the recruiter.
Join our happy subscribers