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Summary:
- Everest Clinical Research is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.
- Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence, evolving into a full-service CRO.
- Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada, with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai, China, and Taipei, Taiwan.
- Everest is known for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs.
- The Senior Clinical Research Associate will support clinical trials across the East Region and may require travel across the USA for monitoring activities.
Responsibilities:
- Interact with personnel from study Sponsors, investigational sites, vendors, and Everest functional groups to ensure quality and on-time execution of clinical trials in compliance with ICH-GCP and local regulations.
- Identify potential sites for participation in clinical trials and perform protocol/site feasibility and Pre-Study Visits.
- Participate in Investigator Meetings and provide training sessions for Clinical Research Associates (CRA) and Study Coordinators.
- Perform Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits as per the approved protocol.
- Submit quality and on-time Monitoring Visit Reports and follow-up letters for review.
- Assist with oversight visits and CRA performance evaluations, providing feedback to supervisors.
- Review ISFs and ensure essential documents are up-to-date and submitted to the Trial Master File (TMF).
- Establish communication with sites and provide ongoing protocol/study-related training.
- Assist with site management tasks such as patient recruitment and retention, data entry, and query resolution.
- Ensure proper handling of investigational products, medical devices, and clinical trial supplies.
- Prepare sites for inspections or audits by regulatory authorities, Sponsors, or CROs.
- Submit accurate and on-time expense reports and assist with materials for Requests for Proposals and bid defenses.
Requirements:
- Bachelor’s degree in Life Sciences or related field.
- Minimum of 4 years of relevant or monitoring experience.
- Thorough knowledge of ICH-GCP guidelines and applicable regulations.
- Strong comprehension of medical terminology.
- Excellent organization and communication skills (both verbal and written).
- Ability to travel up to 70% of working hours to various locations in the USA.
- Must maintain a valid driver’s license and be able to drive to monitoring sites.
Benefits:
- Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity.
- Offers opportunities for professional development and growth within the organization.
- Provides a supportive and flexible work environment.
