Senior Clinical Research Associate (Pain/Oncology/CNS Therapeutic Areas).
Key Accountabilities:- 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.
Qualifications and Experience:- 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. Less travel hours may apply for projects with remote/virtual visits.
- Must maintain a valid driver's license and be able to drive to monitor sites.
Benefits & Compensation:We offer a robust benefits package to support your health, well-being, and growth, including 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, and the opportunity to earn a performance based bonus.
Estimated Salary Range: $ 125,000 - 145,000.
We thank all interested applicants, however, only those selected for an interview will be contacted.
