Oversees the development of clinical trial protocols; participates in the development of the overall clinical plan, drafts protocols and coordinates the protocol review and approval process, to include submissions to regulatory agencies.
Participates in the identification of potential investigators and clinical sites, conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites.
Assists / Coordinates with Site, Vendors, Client, Regulatory & CRO to maintain best practices throughout the course of the study
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 (if applicable) and prepares reports.
For patient PK studies: Oversees subjects visits activities; such as check-in activities, study IP administration, samples collection, process, storage and transport as per the protocol and study specific manuals.
Monitor and track subject enrollment and study progress; Ensure the timely, accurate, complete collection and submission of study data
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 close out of clinical studies by identifying items and issues for review and/or follow-up; assembles necessary documents, conducts site close out visits to include test article reconciliation and disposition, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study close out reports.
Assist the Sponsor/CRO in problem Identification, address issues and problems (as they might occur) and resolve by providing consultation on monitoring and study related activities to ensure 100% adherence to the Protocol, study plans, GCP, applicable regulatory requirements and company SOPs.
Prepare the site for possible Internal and/or Client Audits & Performs miscellaneous job-related duties as assigned.
Ready to travel and perform activities
Data will be coming soon..Data will be coming soon..Data will be coming soon..Data will be coming soon..