Clinical Research Coordinator II

Position: Clinical Research Coordinator II (Full-Time/Non-Exempt)

Responsible for the overall management of the studies assigned to your administrative duties (regulatory functions). Responsible for clear and direct communication with study sponsor, study monitor and CRO, PI and site manager. Adherence to site SOPs is required.

Reports to: Site Manager

Job Description:

The Clinical Research Coordinator (CRC II) manages the daily operations of assigned clinical trials. It is the responsibility of the CRC II to communicate with the investigator, sponsor and study participants all necessary information of the study. It is the responsibility of the CRC II to problem solve issues that may arise and to represent himself/herself and the site in the most professional, ethical and positive manner.

• Inform study participants or caregivers about study procedures and outcomes to be expected
• Train study team members and monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies
• Have all source documentation filled out and completed while the study participants visit is occurring and while the study participant is on site for optimal accuracy of data collection
• Have all source documentation completed, entered into EDC within 48 hours of study participants visit
• Inventory lab and study supplies. Order supplies or delegate to Research Assistant to order needed supplies
• Attend investigator meetings with principle investigator: asks questions and collects pertinent study information while at investigator meeting
• Attend site initiation visits from various drug sponsors and conduct site initiation tours
• Confer with business/recruitment department to determine the best recruitment practices for studies
• Maintain required records of study activity including case report forms, 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 taking laboratory specimens
• Record adverse event and side effect data and confer with investigators regarding the reporting of 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 query being issued by sponsor
• Dispense medical devices or drugs, and calculate dosages, drug compliance and provide instructions as necessary
• Drug Accountability. Logging new medication shipments and reporting to sponsor received and if lost or damaged. Logging dispensed medication to study participants in appropriate medication log
• Initiate and maintain accurate master logs for each study. (ICF, study participants ID, and enrollment)
• Prepare for or participate in quality assurance audits
• Label and organize space for drug. All drug received should be put in drug cabinets immediately once drug arrives to site after being checked in and logged into the drug log
• Maintain accurate temperature logs daily as needed
• Prepare study participants source documents prior to study participants visit
• Maintain training logs on all up-to-date studies
• Maintain and update study delegation logs
• Maintains all safety reports for all studies. Make sure that PI is aware of safety reports to be completed and signs off in a timely manner
• Other duties as assigned

Required Skills/Abilities:

• Experience leading 3-5 studies preferred
• Ability to work independently and as a member of a team

Education and Experience:

• GED or HS Diploma required (Some College preferred)
• 2 - 5 years clinical research experience required

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift up to 15 pounds at times