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

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with personnel from study Sponsors, investigational sites, vendors, and Everest functional groups to ensure high-quality and timely execution of clinical trials in accordance with ICH-GCP and relevant local regulations.

• Identify prospective sites for involvement in clinical trials.

• Conduct protocol/site feasibility assessments and Pre-Study Visits to recommend suitable sites.

• Engage in Investigator Meetings, Clinical Research Associate (CRA) and Study Coordinator training sessions, while assisting sites with study-related inquiries as required.

• Provide input on study manuals, Case Report Form completion guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools, as necessary.

• Execute Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in accordance with the approved protocol and monitoring plan.

• Deliver high-quality and timely Monitoring Visit Reports and follow-up letters to the Clinical Operations Lead or designee for review and approval via the Clinical Trial Management System (CTMS).

• Complete monitoring visit reports and follow-up letters, detailing significant findings, deviations, deficiencies, and recommended actions to ensure compliance at the site.

• Aid in oversight visits and the review/approval of monitoring visit reports for CRA I/II, assessing their performance and providing feedback to their supervisor, if requested.

• Review Investigator Site Files (ISFs) to confirm that essential documents are up to date and submitted to the Trial Master File (TMF) throughout the trial for reconciliation purposes.

• Ensure that sites have submitted necessary documents to their Institutional Review Board/Ethics Committee as required.

• Establish consistent communication channels and provide ongoing protocol/study-related training to assigned sites.

• Support site management tasks and ensure uninterrupted data flow (e.g., timely site data entry, query resolution, and source document verification).

• Evaluate the clinical research site's patient recruitment and retention success, offering suggestions for enhancements.

• Prepare sites for inspections/audits conducted by regulatory authorities, Sponsors, or Contract Research Organizations.

• Submit precise and timely expense reports.

• Assist in preparing materials for Requests for Proposals and bid defenses.

• Support the Clinical Operations team with additional related tasks as required.

• Plan and execute professional development activities.

• Complete timesheets as requested and in a timely manner.

⛳️ Requirements

• Bachelor’s degree in a Life Science or a related field of study.

• A minimum of 4 years of relevant and/or monitoring experience.

• Comprehensive knowledge of ICH-GCP guidelines and applicable regulations.

• Proven experience working on clinical trials in Pain (acute and chronic), Oncology, and CNS therapeutic areas.

• Strong understanding of medical terminology.

• Exceptional organizational and communication skills (both verbal and written).

• Willingness to travel up to 70% of working hours to locations nationwide.

• Must possess 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.