Clinical Research Coordinator

The Clinical Research Coordinator (CRC I) supports the daily operations of assigned clinical trials. It is the

responsibility of the CRC I to communicate with CRC II or CRC III, site manager and study participants regarding
necessary information of the study. Adherence to site SOPs is required.

Reports to: Site Manager/Director

Job Description:

• Inform patients or caregivers about study procedures and outcomes to be expected
• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and statevregulatory and institutional policies
• Have all source documentation filled out and completed while the patient visit is occurring and while thevpatient is on site for optimal accuracy of data collection
• Have all source documentation completed, entered into EDC within 48 hours of patient visit
• Inventory lab and study supplies. Notify manager when supplies need to be ordered
• Maintain required records of study activity including case report forms, drug dispensation records
• Perform specific protocol procedures such as interviewing subjects, taking vital signs, performingvelectrocardiograms and taking laboratory specimens
• Record adverse event and side effect data and confer with investigators regarding the reporting of eventsvto sponsors
• Resolve all auto queries in the EDC within 24 hours of query being issued by sponsor
• Dispense medical devices or drugs, and calculate dosages, drug compliance and provide instructions asvnecessary
• Drug Accountability. Logging new medication shipments and reporting to sponsor received and if lost orvdamaged. Logging dispensed medication to subjects in appropriate medication log
• Initiate and maintain accurate master logs for each study. (ICF, patient ID, and enrollment).
• Participate in quality assurance audits
• Label and organize space for drug. All drug received should be put in drug cabinets immediately oncevdrug arrives to site after being checked in and logged into the drug logs
• Maintain accurate temperature logs daily as needed
• Other duties as assigned

Required Skills/Abilities:

• 6 months - 2 years clinical research experience preferred
• Ability to work independently and as a member of a team