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Lead Clinical Research Specialist
2 months ago
Company Overview:
Everest Clinical Research Services Inc. is a premier contract research organization (CRO) delivering a comprehensive suite of expertise-driven clinical research solutions to global pharmaceutical, biotechnology, and medical device sectors. We collaborate with some of the most recognized companies and engage with numerous advanced therapeutics, biologics, and medical devices currently under development.
Established as an independent CRO in 2004, Everest has built a robust foundation as a center of excellence in statistical analysis and data management. Leveraging this foundation, we have successfully evolved into a full-service CRO. Our headquarters are situated in Markham, Ontario, Canada, with additional operational sites in various strategic locations.
Renowned for our commitment to high-quality deliverables, exceptional customer service, and adaptability to meet client needs, Everest is a dynamic organization with an entrepreneurial spirit, consistently achieving remarkable growth and success.
Position Overview:
To sustain our momentum in the dynamic field of clinical research, we are in search of dedicated, skilled, and client-oriented professionals to fill the role of Senior Clinical Research Associate. This position will primarily focus on the West Region, with potential travel across various locations to support monitoring activities as required.
Key Responsibilities:
- Engage with stakeholders from study sponsors, investigational sites, vendors, and internal teams to ensure the quality and timely execution of clinical trials in accordance with ICH-GCP and applicable local regulations.
- Identify and evaluate potential sites for participation in clinical trials.
- Conduct protocol/site feasibility assessments and Pre-Study Visits to recommend qualified sites.
- Participate in Investigator Meetings and training sessions for Clinical Research Associates and Study Coordinators, providing assistance with study-related inquiries as necessary.
- Offer constructive feedback on study manuals, Case Report Form guidelines, monitoring plans, informed consent documents, recruitment materials, and monitoring tools.
- Conduct Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in alignment with the approved protocol and monitoring plan.
- Prepare and submit comprehensive Monitoring Visit Reports and follow-up correspondence for review and approval.
- Compile monitoring visit reports, detailing significant findings, deviations, deficiencies, and recommended corrective actions to ensure site compliance.
- Assist in the oversight and evaluation of CRA I/II performance during monitoring visits, providing feedback as requested.
- Review essential documents to ensure they are current and submitted to the Trial Master File (TMF) throughout the trial, maintaining an inspection-ready state.
- Establish consistent communication and provide ongoing protocol/study-related training to assigned sites.
- Support site management tasks to ensure continuous data flow, including timely site data entry, query resolution, and source document verification.
- Ensure proper handling and accountability of all investigational products and clinical trial supplies.
- Prepare sites for inspections or audits conducted by regulatory authorities or sponsors.
- Submit accurate and timely expense reports.
- Assist in the preparation of materials for Requests for Proposals and bid defenses.
- Support the Clinical Operations team with additional related tasks as needed.
- Engage in professional development activities.
- Complete timesheets accurately and on time.
Qualifications:
- Bachelor's degree in a Life Science or a related field.
- A minimum of 4 years of relevant experience in clinical research or monitoring.
- In-depth knowledge of ICH-GCP guidelines and applicable regulations.
- Strong understanding of medical terminology.
- Excellent organizational and communication skills, both verbal and written.
- Willingness to travel up to 70% of working hours to various locations, with potential for remote/virtual visits.
- Must possess a valid driver's license and be capable of driving to monitor sites.
