Clinical Research Associate (II)
In-House Clinical Research Associate
Manager, Clinical Operations
· 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.