Clinical Research Coordinator III
Under the direction of the Study Investigators and Disease Team Chair, the supervision of the Clinical Trial Administrators and the leadership of the Clinical Research Nurse Manager, the CRC III coordinates activities to support multiple research studies of all phases and all levels of complexity, including investigator-initiated, IND, First-In-Human, gene therapy or other high profile trials. Functions independently and proficiently with minimal oversight. Serves as the principle administrative liaison for assigned studies and as a technical resource for the department. Develops and maintains recordkeeping systems and procedures to ensure compliance with study protocols and all appropriate regulations. Attends clinic as needed to perform activities including, but not limited to: assist the research team with recruitment activities, administer questionnaires and answer any questions about future appointments. Responsible for the compilation, registration and submission of data, as required by the Sponsor. Mentors and supports new and less experienced staff.
Key Responsibilities include:
Works under the direction of the Study Investigators with minimal supervision by the Clinical Trials Administrator and direction from the Clinical Research Nurse Manager.
Plays an active role in recruitment of patients to study.
Performs protocol specific duties required per the research protocol, including:
Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families.
Confirms and documents subject eligibility.
As part of the team, ensures all protocol procedures are ordered and completed as specified in the protocol.
Randomizes subjects using interactive voice response systems or other systems as applicable.
Administers standardized tools or questionnaires, such as Quality of Life assessments, if appropriately credentialed.
Assembles lab kits and other supplies in preparation to obtain required biospecimen samples and transports to appropriate laboratories for processing; ships samples externally according to IATA requirements.
Optimizes the safety of research subjects by monitoring and reporting any adverse events to the investigators and other members of the study team.
Participates in required teleconferences, on site meetings and off site investigator meetings, as required.
Hosts site initiation visits and monitoring or auditing visits.
Regulatory Compliance and Documentation.
Minimum Education and Skills Required for Consideration:
Must have a Bachelor’s Degree.
Must have six of more years of experience as a Clinical Research Coordinator.
Ability to access data in computer data bases, compile data, proofread documents, research information, troubleshoot problems, use computer packages and use word-processing software.
SOCRA or ACRP certification