Senior Clinical Research Associate – Pain, Oncology, CNS Therapeutic Areas

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🕒 July 3

🇺🇸 United States – Remote

💵 $125k - $145k / year

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 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. • 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

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