Senior Clinical Research Associate – Pain, Oncology, CNS Therapeutic Areas
Job Description:
• 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.
• The CRA is responsible for ensuring that the TMF is maintained in an inspection-ready state.
• 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.
Benefits:
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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.
• The CRA is responsible for ensuring that the TMF is maintained in an inspection-ready state.
• 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.
Benefits:
Apply tot his job
Apply To this Job