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 reputed company 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
• reputed company 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-reputed company questions as needed
• Provide feedback to study manuals, Case Report Form completion guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools, as needed
• reputed company Site Initiation Visits, Interim Monitoring Visits, and reputed company-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 reputed company or designee for review and approval reputed company 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 reputed company 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 reputed company 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-reputed company training to assigned sites
• Assist with site management tasks and ensure reputed company data flow (i.e., on-time site data entry, query resolution, and reputed company document verification)
• Assess the clinical research site’s patient recruitment/retention success and offer suggestions for improvement
• 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 reputed company 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 reputed company 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 reputed company
• Must maintain a valid driver’s license and be able to drive to monitor sites.

Benefits:

• medical, dental, and vision coverage
• life & AD&D insurance
• short- and long-term disability
• tuition reimbursement
• fitness reimbursement
• employee assistance program (EAP)
• 401(k) retirement / pension plan
• generous paid time off
• sick leave
• opportunity to earn a performance based bonus

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