** ICON/ Accellacare is hiring Clinical Research Coordinators. Openings are on site so must be commutable to Wilmington, North Carolina.
CRC Level 1
Job Description Summary
Ensures the safety of our volunteers. Promotes the mission of PMG to function as an Integrated Site Network. Consistently strives to meet and exceed priorities as discussed with direct supervisor. Actively recruiting and promoting our service to suitable participants and sponsor representatives. Performing tasks required to coordinate and complete a study according to the protocol and maintaining communication with the Manager of Clinical Operations regarding training, orientation, or other concerns regarding the coordination of clinical trials.
Job Description
• Develop and maintains proper skills to comply with the protocol, federal regulatory requirements, internal SOP’s, and COG’s
• Performs study start-up duties including the production of a recruitment plan, recruitment tool, and progress notes, as well as phone screening participants.
• Completes training on Clinical Trial Management System and maintains proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment.
• Communicates with the Manager of Clinical Operations regarding training/orientation, recruitment efforts, the overall status of a trial(s), and other concerns.
• Attends investigator meetings.
• Creates and updates source documents/progress notes and utilizes templates provided in the Core Operating Guidelines.
• Accurately collects study data via source documents/progress notes as required by the protocol.
• Performs technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol.
• Performs continuous reviews of the inclusion and exclusion criteria for each participant during the screening period.
• Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events.
• Builds strong relationships with Investigators and provides ongoing communication about trial status and participants.
• Dispenses study medication at the direction of the Investigator.
• Maintains communication with the monitor from the sponsoring company through telephone contact, written communication, and on-site visits.
• Enters visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF) within timelines provided by sponsor.
• Addresses all queries or data clarifications within 48 hours of receipt.
• Meets with the Clinical Research Associate at each scheduled monitoring visit and is available to complete queries or data clarifications in timely manner during these visits.
• Reports protocol violations and significant deviations to the Manager of Clinical Operations.
• Establishes relationships with volunteers, and participates in patient education regarding the clinical trial process and provides specific trial information to the participant as well as conducting the informed consent process.
• Assists other staff members as determined by the needs and priorities of the research organization and as time and abilities permit.
• Anticipates possible problems and resolutions with job responsibilities as these responsibilities apply to our mission statement.
• Prepares study documentation in the event of a PMG, sponsor, or FDA audit and
assists the auditor for the duration of the audit including correcting
discrepancies in a timely manner.
• Travel: Travel to other sites within the network may be required to support increases in workload and, or studies/projects as needed.
