Lead Clinical Research Specialist

2 weeks ago

Kansas City, Missouri, United States Everest Clinical Research Services Inc Full time

Company Overview:

Everest Clinical Research Services Inc. is a premier contract research organization (CRO) dedicated to 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 renowned companies and are involved with many of the cutting-edge drugs, biologics, and medical devices currently in 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. Expanding upon this foundation, we have successfully evolved into a full-service CRO. Our headquarters are strategically located in the Greater Toronto Area, with additional operational sites in various key regions.

Known for our commitment to quality, exceptional customer service, and adaptability to meet client needs, Everest is a dynamic organization with a strong entrepreneurial spirit, consistently achieving remarkable growth and success.

Position Overview:

To sustain our ongoing success 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, and travel may be required to support monitoring activities as necessary.

Key Responsibilities:

  • Engage with personnel from study sponsors, investigational sites, vendors, and internal teams to ensure quality and timely execution of clinical trials in adherence to ICH-GCP and relevant 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 needed.
  • Offer constructive feedback on study manuals, Case Report Form guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools.
  • Execute Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring plan.
  • Deliver high-quality and timely Monitoring Visit Reports and follow-up letters for review and approval.
  • Compile monitoring visit reports, summarizing significant findings, deviations, deficiencies, and recommended actions to ensure site compliance.
  • Assist with oversight visits and review/approval of CRA I/II monitoring visit reports, providing performance feedback to supervisors as requested.
  • Review essential documents to ensure they are current and submitted to the Trial Master File (TMF) throughout the trial.
  • Establish effective communication channels and provide ongoing protocol/study-related training to assigned sites.
  • Support site management tasks and 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 and audits conducted by regulatory authorities or sponsors.
  • Submit accurate and timely expense reports.
  • Assist with the preparation of materials for Requests for Proposals and bid defenses.
  • Support the Clinical Operations team with additional related tasks as required.
  • Engage in professional development activities.
  • Complete timesheets as requested 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.
  • Possession of a valid driver's license and ability to drive to monitor sites.

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