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Interact with personnel from study Sponsors, investigational sites, vendors, and Everest functional groups to enable quality and on-time execution of clinical trials in compliance with ICH-GCP and relevant local regulations.
Identify potential sites for participation in clinical trials.
Perform protocol/site feasibility and Pre-Study Visits to recommend qualified sites.
Participate in Investigator Meetings, Clinical Research Associate (CRA) and Study Coordinator training sessions, and assist sites with study-related questions as needed.
Provide feedback to study manuals, Case Report Form completion guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools, as needed.
Perform Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring plan.
Submit quality and on-time Monitoring Visit Reports and follow-up letters to the Clinical Operations Lead or designee for review and approval via Clinical Trial Management System (CTMS).
Complete monitoring visit reports and follow-up letters, including summaries of the significant findings, deviations, deficiencies, and recommended actions to ensure site compliance.
Assist with oversight visits and monitoring visit report review/approval of CRA I/II, evaluating their performance and providing feedback to their supervisor, if requested.
Review ISFs to ensure essential documents are current and submitted to the TMF throughout the trial for reconciliation purposes.
Ensure sites have submitted relevant documents to their Institutional Review Board/Ethics Committee as needed.
Establish regular lines of communication and administer ongoing protocol/study-related training to assigned sites.
Assist with site management tasks and ensure continuous data flow (i.e., on-time site data entry, query resolution, and source document verification).
Assess the clinical research site’s patient recruitment/retention success and offer suggestions for improvement.
Ensure proper handling, accountability, and reconciliation of all investigational products, medical devices, and clinical trial supplies.
Prepare sites for inspections/audits conducted either by regulatory authorities, Sponsors, or Contract Research Organizations.
Submit accurate and on-time expense reports.
Assist with preparation of materials for Requests for Proposals and bid defenses.
Assist the Clinical Operations team with additional related tasks as needed.
Plan and carry out professional development.
Complete timesheets as requested and on-time.
Requirements:
Bachelor’s degree in a Life Science or related field of study
Minimum of 4 years’ of relevant and/or monitoring experience
Thorough knowledge of ICH-GCP guidelines and applicable regulations
Demonstrated experience working on clinical trials across Pain (acute and chronic), Oncology, and CNS therapeutic areas
Thorough comprehension of medical terminology
Excellent organization and communication skills (both verbal and written)
Ability to travel a maximum of 70% of working hours to locations nationwide.
Must maintain a valid driver’s license and be able to drive to monitor sites.
