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Senior Clinical Research Associate
2 months ago
Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing comprehensive clinical research services to pharmaceutical, biotechnology, and medical device industries worldwide.
Key Responsibilities:- Collaborate with study sponsors, investigational sites, vendors, and internal teams to ensure high-quality and timely execution of clinical trials in compliance with ICH-GCP and relevant regulations.
- Identify and recommend qualified sites for participation in clinical trials.
- Conduct protocol/site feasibility assessments and pre-study visits to ensure site readiness.
- Participate in investigator meetings, CRA training sessions, and provide support to sites with study-related queries.
- Review and provide feedback on study manuals, case report forms, monitoring plans, informed consents, recruitment materials, and monitoring tools.
- Perform site initiation visits, interim monitoring visits, and close-out visits in accordance with approved protocols and monitoring plans.
- Submit quality and timely monitoring visit reports and follow-up letters for review and approval.
- Assist with oversight visits and monitoring visit report review/approval of CRA I/II, evaluating their performance and providing feedback.
- Review and ensure essential documents are current and submitted to the TMF throughout the trial for reconciliation purposes.
- Establish regular communication and administer ongoing protocol/study-related training to assigned sites.
- Assist with site management tasks and ensure continuous data flow, including on-time site data entry, query resolution, and source document verification.
- Ensure proper handling, accountability, and reconciliation of investigational products, medical devices, and clinical trial supplies.
- Prepare sites for inspections/audits conducted by regulatory authorities, sponsors, or CROs.
- Submit accurate and timely expense reports.
- Assist with preparation of materials for Requests for Proposals and bid defenses.
- Support the Clinical Operations team with additional related tasks as needed.
- Bachelor's degree in a Life Science or related field.
- Minimum 4 years' relevant and/or monitoring experience.
- Thorough knowledge of ICH-GCP guidelines and applicable regulations.
- Excellent organization and communication skills.
- Ability to travel up to 70% of working hours to locations nationwide.
- Valid driver's license and ability to drive to monitor sites.
Everest Clinical Research Services Inc is a dynamic organization with a strong foundation in statistical and data management expertise. We are committed to delivering high-quality services and building long-term relationships with our clients.
