Clinical Research Coordinator III – McKinney, TX

Accountable for the comprehensive oversight of clinical studies, encompassing both administrative tasks and regulatory responsibilities. Ensures clear and direct communication with the study sponsor, study monitor, CRO, PI, and site manager. Compliance with site SOPs is mandatory.

The Clinical Research Coordinator (CRC III) oversees the daily operations of assigned clinical trials. The CRC III is responsible for conveying all essential study information to the investigator, sponsor, and study participants. Additionally, the CRC III must address and resolve any issues that arise, while representing themselves and the site in a professional, ethical, and positive manner.

• Inform study participants or caregivers about study procedures and anticipated outcomes.
  

• Train study team members and monitor study activities to ensure adherence to protocols and all relevant local, federal, and state regulatory and institutional policies.
  

• Complete source documentation during the study participants’ visit on-site to ensure optimal accuracy of data collection.
  

• Enter completed source documentation into the EDC within 48 hours of the study participants’ visit.
  

• Inventory lab and study supplies, and order supplies or delegate the task to a Research Assistant as needed.
  

• Attend investigator meetings with the principal investigator, ask questions, and collect relevant study information.
  

• Attend site initiation visits from various drug sponsors and conduct site initiation tours.
  

• Confer with the business/recruitment department to identify the best recruitment practices for studies.
  

• Maintain required records of study activities, including case report forms and drug dispensation records.
  

• Communicate with laboratories or investigators regarding laboratory findings.
  

• Order drugs or devices necessary for study completion.
  

• Direct the requisition, collection, labeling, storage, or shipment of specimens.
  

• Perform specific protocol procedures, such as interviewing study participants, taking vital signs, performing electrocardiograms, and collecting laboratory specimens.
  

• Record adverse event and side effect data, and confer with investigators about reporting events to sponsors.
  

• Maintain contact with sponsors to schedule and coordinate site visits/monitoring visits.
  

• Resolve all auto queries in the EDC within 24 hours of the query being issued by the sponsor.
  

• Dispense medical devices or drugs, calculate dosages, monitor drug compliance, and provide instructions as necessary.
  

• Maintain drug accountability by logging new medication shipments, reporting any received or lost/damaged shipments to the sponsor, and logging dispensed medication to study participants in the appropriate medication log.
  

• Initiate and maintain accurate master logs for each study, including ICF, patient ID, and enrollment logs.
  

• Prepare for or participate in quality assurance audits.
  

• Label and organize space for drugs, ensuring all received drugs are placed in drug cabinets immediately after being checked in and logged.
  

• Maintain accurate daily temperature logs as needed.
  

• Prepare study participants’ source documents prior to patient visits.
  

• Maintain up-to-date training logs for all studies.
  

• Maintain and update study delegation logs.
  

• Retain all safety reports for all studies, ensuring the PI is aware of safety reports that require completion and timely sign-off.
  

• Function as a subject matter expert in Clinical Research to provide support and guidance to peers.
  

• Other duties as assigned

Requirements:

• GED or HS Diploma required (Some College preferred)
  

• 5+ years clinical research experience required
  

• Experience leading 6-8 studies preferred
  

• Ability to work independently and as a member of a team

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