Summary

The Research Coordinator is responsible for the comprehensive management and oversight of clinical study programs, ensuring their seamless operation and strict adherence to regulatory standards.

Essential Duties and Responsibilities

To effectively fulfill this role, the individual must competently perform each essential function, with or without reasonable accommodation.

  • Regulatory Compliance:
    • Ensure studies are conducted in accordance with FDA and OHRP regulations.
    • Review regulatory requirements to implement appropriate methods, practices, and procedures for all research activities.
    • Develop accurate source materials and ensure compliance by site staff.
    • Ensure timely and precise data collection, documentation, entry, and reporting in both sponsor and OMRC databases.
    • Ensure appropriate credentialing and training of the research team as required for all studies and protocols.
    • Maintain regulatory documentation in compliance with sponsor, site requirements, and applicable regulations.
    • Interface with research participants to determine eligibility and secure consent according to protocol.
  • Communication and Collaboration:
    • Communicate and collaborate with the research team, including internal and external parties, sponsors, monitors, PI, and study participants.
    • Participate with the PI and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance.
  • Quality Control and Audits:
    • Ensure compliance with research protocols through ongoing quality control audits.
    • Maintain investigational drug accountability.
    • Distribute investigational drugs and provide patient instructions on administration, including daily temperature monitoring of all investigational products.
    • Monitor and record temperatures of all study products.
  • Administrative Responsibilities:
    • Retrieve and respond to communications from the clinical study email inbox.
    • Prepare and organize patient charts.
    • Order supplies for the study department.
    • Schedule appointments for all study participants.
    • Assist providers with ECG procedures.
    • Process and prepare samples for shipment.
    • Dispose of lab and study supplies in accordance with OSHA guidelines.
    • Ensure all study equipment is operational.
    • Process orders for new studies.
    • File documents as needed.
    • Train on study systems.
    • Attend study initiation visits and investigator meetings.
    • Set up electronic devices for study subjects.
    • Maintain regular and reliable attendance.
    • Perform other duties as assigned.
    • Maintain and confirm all necessary certifications for all study team members.

Additional Information

  • Public Facing Role: This position primarily serves external customers, including patients, centers of influence, vendors, and community leaders, as well as review committees.

Knowledge, Skills, and Abilities

  • Education: High school diploma or equivalent.
  • Experience:
    • 1-3 years of experience in clinical study operations, preferably in a coordinator role.
    • Certified Clinical Research Coordinator or 3,000 hours of relevant experience.
    • The ideal candidate will be detail-oriented, self-motivated, and capable of executing all duties compliantly.
  • Technology Applications: Proficiency in Microsoft Office applications.
  • Role-Specific Knowledge:
    • Medical terminology
    • HIPAA privacy laws
  • Certifications: CPR Certification is preferred.

Physical and Mental Demands

  • Occasionally required to stand, walk, and sit for extended periods.
  • Use hands to finger, handle, or feel objects, tools, or controls.
  • Reach with hands and arms; climb stairs; balance, stoop, kneel, bend, crouch, or crawl.
  • Communicate effectively through talking and hearing.
  • Occasionally lift, push, pull, and/or move up to 20 pounds.
  • Engage in repetitive motion of the upper body due to extended computer use.
  • Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

Work Environment and Travel Requirements

  • Work in a well-lit, ventilated, and climate-controlled office environment with routine office equipment; some equipment may have moving mechanical parts.
  • Noise level in the work environment is typical for an office and/or medical clinic environment.
  • The role may require occasional weekend and/or overnight travel for investigator meetings.

NOTE:  This job description may not include all of the duties assigned to the employee and may be updated and modified by the department supervisor, according to the operations at any given time.