CRA job in San Francisco, USA

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Job type: Permanent

Discipline: Clinical Research Associate (CRA), CRA Manager

Location: United States

This vacancy has now expired. Please see similar roles below...

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.

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