Note: The job is a remote job and is open to candidates in USA. Everest Clinical Research is a full-service contract research organization providing expertise-based clinical research services to pharmaceutical, biotechnology, and medical device industries. They are seeking a Senior Clinical Research Associate to ensure quality and timely execution of clinical trials while interacting with various stakeholders and managing site-related activities.
Responsibilities
- 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
Skills
- 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
- 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
- The opportunity to earn a performance based bonus
Company Overview
Everest Clinical Research is a firm which conducts clinical research by contract for firms across the globe in fields It was founded in 2004, and is headquartered in Markham, Ontario, CAN, with a workforce of 501-1000 employees. Its website is https://www.ecrscorp.com/.