Clinical Research Associate I
Job Req code: 957
Category: Clinical Affairs
Monitors/Co-monitors investigational study sites and performs in-house site management functions for ongoing clinical trials at Organogenesis in accordance with GCP guidelines, FDA or other applicable regulatory agency regulations and internal; responsible for review and collection of clinical data and regulatory documents at designated study sites; acts as primary site contact; works closely with CPM to manage and execute investigational studies and fulfill program goals and timelines; 50% travel, US and Canadian sites; CRA will be based in-house at Organogenesis when not traveling.
The job responsibilities of the Clinical Research Associate include but are not limited to the following:
Conducts all aspects of site monitoring including pre-study selection/qualification visits, site initiation visits, interim monitoring visits, and close-out visits as well as completion of site visit reports and site follow-up in a timely manner.
Ensures site staff has the proper materials and training to safely and appropriately conduct the study.
Verifies the ongoing suitability of investigators and site facilities throughout the conduct of a clinical study.
Ensures the protection of study patients by verifying informed consent procedures and protocol requirements are followed.
Ensures data integrity by careful source document review, CRF entry validation, and data clarification resolution.
Ensures Adverse Events (AEs), Serious Adverse Events (SAEs), Protocol Deviations (PDs) and Device Malfunctions (DVs) are reported according to protocol guidelines.
Ensures investigational product is accounted for and substantiating documentation is maintained.
Reviews and collects site regulatory documents and reconciles them with the Organogenesis Trial Master File.
Assists in study start-up activities (i.e. preparation of protocols, CRFs, ICF document, Regulatory Binders, etc.; investigator site recruitment/selection; planning of Investigator Meetings).
Tracks the day-to-day progress of clinical site activities and updates the appropriate clinical tracking systems at regular intervals.
Responsible for managing specific day-to-day Clinical Operation tasks as assigned.
Maintains effective communication via written, oral and /or electronic contacts.
Completes all clinical, corporate, and project specific training and attends meetings as required.
Assists with planning for and presenting at investigator meetings.
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