About the job
Duties and Responsibilities
- Oversees the development of clinical trial protocols; participates in the development of the overall clinical plan, drafts protocols, collaborates on statistical analysis plans, and coordinates the protocol review and approval process, to include submissions to regulatory agencies.
- Participates in the identification of potential investigators and clinical sites, both nationally and internationally; conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites.
- Assists in the identification of contract research organizations and centralized services such as clinical laboratories; assesses qualifications and experience in relation to proposed research activities, and participates in final selection.
- Oversees research technical and/or administrative staff, to include hiring, training, goal-setting, and distribution of workload.
- Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in the establishment of baseline parameters and edit check specifications, and in the development of subject tracking systems.
- Conducts clinical trial site initiation visits; advises and trains site personnel on sponsor and regulatory requirements for study conduct; participates and/or conducts site meetings and multicenter investigator meetings and prepares reports.
- Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies.
- Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required.
- Ensures appropriate transmission of clinical case data to the data management centers; reviews case report queries and problems, and clarifies and/or obtains changes to data as appropriate.
- Assists in the termination of clinical studies by identifying items and issues for review and/or follow-up; assembles necessary documents, conducts site termination visits to include test article reconciliation and disposition, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study termination reports.
- Performs miscellaneous job-related duties as assigned.
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