Plans, organizes, and manages the resources necessary to achieve clinical research project goals and objectives at a single site.
Coordinates and performs patient clinical assessments for clinical trial visits for assigned clinical trial protocols including scheduling with vendors which may include other departments or outside facilities. This may include phlebotomy, sample processing, vitals, ECGs and other delegated clinical assessments per assigned protocols.
Communicates as a site representative with study sponsors, third party vendors, clinical teams and patients to ensure all protocol required elements are being completed and collected within the defined windows.
Ensures site compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends site monitoring meetings with sponsors.
Manages the site research project databases, develops flowsheets and other study related documents, and completes source documents/case report forms.
May provide guidance to other clinical research staff and support personnel.
Makes recommendations of procedures in order to facilitate protocol compliance.
Performs data entry and query resolution during the duration of each trial assigned.
Serve as a resource for both internal and external customers and members of the community in regard to clinical research processes at the site

OPS Program Manager

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