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University of Colorado - Aurora, CO

posted 2 months ago

Full-time - Entry Level
Onsite - Aurora, CO
251-500 employees
Educational Services

About the position

The Clinical Research Coordinator (CRC) at the University of Colorado Anschutz Medical Campus will oversee and assist with the daily operations of clinical trials at the Satellite Office in Cherry Creek. This role involves ensuring compliance with research protocols, managing subject recruitment, and collaborating with hospital staff to facilitate clinical research activities. The position is available at three levels (Entry, Intermediate, and Senior), each with increasing responsibilities and expectations.

Responsibilities

  • Assist with and oversee the day-to-day operations of clinical trials and studies
  • Obtain study subject's medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial
  • Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
  • Interview prospective subjects for a variety of research clinical trials and educate them on the details of the studies
  • Schedule subject participation in research clinical trials, coordinating availability of necessary space and clinical research support
  • Collaborate with hospital staff to ensure tests and procedures required by research protocols are performed and documented
  • Meet with Monitors to respond to any questions of data validity and correct/revise data as appropriate
  • Adhere to research regulatory standards and maintain detailed records of studies
  • Assist with Sponsor, Data Safety Monitoring, and FDA audits and responses
  • Participate in subject recruitment efforts, including communicating with patients expressing interest and all pre-screening/screening activities
  • Ensure that necessary supplies and equipment for studies are in stock and in working order
  • Independently master study materials and perform study-related processes as defined in study protocol
  • Assist Team Leads and management with creation and implementation of processes and procedures
  • Act as a Primary Coordinator on multiple trials/studies
  • Assist with developing protocol-specific systems and documents, including process flows and training manuals
  • Identify issues related to operational efficiency and share results with leadership
  • Serve as a resource and participate in study initiation and close out duties

Requirements

  • Bachelor's degree in any field
  • One (1) year of professional clinical research experience and/or professional clinical experience post Bachelor's degree for Intermediate Level
  • One (1) year of professional clinical research experience and one (1) year of professional clinical experience post Bachelor's degree for Senior Level
  • Knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
  • Ability to communicate effectively, both in writing and orally
  • Ability to establish and maintain effective working relationships with employees at all levels
  • Outstanding customer service skills
  • Demonstrated commitment and leadership ability to advance diversity and inclusion
  • Knowledge of basic human anatomy, physiology, and medical terminology
  • Ability to interpret and master complex research protocol information

Nice-to-haves

  • Bachelor's degree in science or health-related field
  • Three (3) years of clinical research or related experience
  • Experience with electronic data capture systems (e.g., EMR or EHR and data management systems)
  • Additional certification (CCRC, CCRP, CCRA)

Benefits

  • Medical: Multiple plan options
  • Dental: Multiple plan options
  • Disability, Life, Vision insurance
  • Retirement 401(a) Plan: Employer contributes 10% of gross pay
  • Paid Time Off: Accruals over the year
  • Vacation Days: 22/year (maximum accrual 352 hours)
  • Sick Days: 15/year (unlimited maximum accrual)
  • Holiday Days: 10/year
  • Tuition Benefit: Access to this benefit on all CU campuses
  • ECO Pass: Reduced rate RTD Bus and light rail service
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