CRA

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.

Job Responsibilities:

• 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 m.jacobs@proclinical.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.

#LI-MJ1