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Clinical Research Associate

Job Title

Clinical Research Associate (II)

Job Description

In-House Clinical Research Associate

Department

Clinical

Reports to:

Manager, Clinical Operations

Job Duties

· Assesses site qualification potential: reviews study requirements; conducts pre-study visits and drafts pre-study evaluation reports.

· Participates in the implementation of clinical studies: communicates with investigators and their staff; ensures compliance with terms and conditions; properly trains site personnel and writes initiation visit reports.

· Supervises the conduct of clinical studies: acts as liaison between site personnel and the sponsor; may perform monitoring in the field if needed; ensures compliance with protocols, regulatory requirements, and good clinical practices; writes follow-up visit reports (as applicable).

· Ensures the quality of the project: verifies materials and data integrity; assists site personnel with internal audits or regulatory inspections; and perform ongoing follow-up with the in-house project team.

· Closes clinical studies: verifies the integrity of investigator files; ensures availability of clinical and non-clinical materials; jointly reviews with investigators the obligations inherent at the end of the study and writes closure visit reports.

· Adheres to protocol regulatory requirements, good clinical practice regulations, and standard operating procedures.

· Assesses the trial site and applicable personnel on an ongoing basis.

· Ensures compliance with the patient-consent process.

· Verifies the receipt, handling, accounting, storage conditions, and availability of clinical products under investigation.

· Verifies compliance and quality of collected data.

· Ensures compliance with the procedures to apply in the event of serious adverse events.

· Drafts an appropriate intervention plan for the avoidance of redundant errors and deviations.

· Verifies investigator records and checks for consistency with the contents of sponsor files.

· Acts as liaison between project managers and research-site personnel.

· Maintains the quality of the work and relationships.

· Monitors the conduct of clinical trials and compliance with established timelines.

· Ensures harmonization of in-house monitoring practices.

· Negotiate clinical trial agreements and budgets

o Liaison with Legal as needed

Sthree US is acting as an Employment Agency in relation to this vacancy.