Proclinical is currently recruiting for a CRA with a leading medical device company located in the west coast. As the CRA, you will be responsible for assessing site qualification potential; reviewing study requirements with prospective sites; conducting site qualification visits; and writing site qualification visit reports.
- Conducts site initiation visits; communicates with investigators and their staff; ensures compliance with terms and conditions; properly trains site personnel according to Good Clinical Practices and the Code of Federal Regulations; and writes site initiation visit reports.
- Supervises the conduct of clinical studies in the field; acts as a liaison between site personnel and the sponsor; performs monitoring visits; ensures compliance with protocols, regulatory requirements, and good clinical practices; discusses subject recruitment and retention; writes monitoring visit reports.
- Perform monitoring for safety reporting adherence, data integrity, query resolution, essential document compliance, drug/device accountability, protocol deviations, ensures all required documentation is filed and maintained in the trial master file.
- Ensures quality of the project; verifies materials/data integrity; assists site personnel with internal audits or regulatory inspections; and perform ongoing follow-up with the in-house project team.
- Conduct in-services training and retraining as required to orient all appropriate personnel (investigator and their staff) and support the field staff in the execution of the clinical study.
- Verifies the integrity of the investigator site files; jointly reviews with investigators the obligations inherent at the end of the study, write closeout visit reports.
- Attends and contributes to the conduct of study surgeon training.
- Serves on study project teams; support project team in the management of clinical sites by providing feedback to study team (SM, CAS, CRO or other appropriate party).
- Adheres to Good Documentation Practices; Good Clinical Practices; Good Tissue Practices; and department Standard Operating Procedures.
Skills and Requirements:
- Must be able to travel (automobile and air transport) and according to travel policy.
- Must be able to occasionally travel on weekends.
- Must comply with applicable ISO and FDA regulations as stated in Quality Manual.
- Must embody the Company's Vision, Mission and Values.
If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at 312-291-4181 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.