Job Title: Clinical Research Data Coordinator (Head & Neck)

Job Description

The primary purpose of the Clinical Research Data Coordinator (Head & Neck) position is to assist in the development and maintenance of a system for controlling paper flow for protocols, and dissemination of data resulting from the protocols. This includes the completion of data forms, treatment records, and review of records before submission to pharmaceutical companies, federal agencies, internal groups, and other institutions. The role also involves coordination of communication between these groups and department physicians regarding research studies.

Responsibilities

• Abstract and collect patient data from electronic health records and other relevant source documents.
• Ensure high quality data management, including tracking receipt, QA, and entry of patient data; entering protocol data into the appropriate database(s) and generating queries for missing or incorrect data.
• Issue nursing/CSC/PI queries, track query return, and follow-up on all delinquent requests.
• Perform ongoing and concurrent review of data to ensure completeness and accuracy; address data entry omissions or inconsistencies and amend errors in a timely manner.
• Assist in database coordination, build, and maintenance for all IIT/IND studies utilizing an institutional database.
• Develop and maintain systems for controlling data flow; develop spreadsheets or other tracking tools for data that cannot be entered into a database.
• Provide data for study progress and patient safety reports, such as IRB continuing reviews and IND reports.
• Create accrual and/or toxicity reports as needed; assist in the collection and evaluation of protocol data and compile protocol data for statistical review/manuscript submission.
• Utilize different institutional databases to obtain and verify patient and protocol information.
• Record data specific deviations to deviation logs as indicated by sponsor request and other governing entities.
• Assist research staff with creation of new user accounts and database support on assigned studies.
• Follow and adhere to national/state, institutional, departmental, and sponsor guidelines to accomplish and complete daily work assignments.
• Prepare protocols for close out visits and termination.
• Consult with principal investigators and other department personnel regarding ongoing studies; gather and report appropriate information.
• Participate in protocol site initiation/logistics meetings and attend departmental or institutional research meetings as well as approved off-site meetings or conferences.
• Process requests for protocol-specific shipments of materials and investigational agents.
• Submit requests for image uploads to sponsor vendor entities and follow-up as necessary.
• Coordinate and communicate frequently with other research staff to identify and address any study-related issues.
• Develop templates/processes to ensure all information needed for data capture is documented.
• Inform research staff and others on upcoming deadlines to ensure data is completed.
• Act as a liaison between the research team, sponsor, CROs, other institutions, and agencies to ensure data is captured accurately and appropriately.
• Maintain a level of professional expertise and credibility through attendance at both institutional and outside continuing education programs.
• Track and manage all relevant protocol paperwork and essential documents.
• Demonstrate excellent oral and written communication skills when contacting other institutions and agencies.
• Coordinate and participate in monitoring visits and internal or external audits to ensure objectives are met.
• Review CD/Zip files of completed data points for preparation of study close-out/termination.
• Maintain adequate supplies for research record storage.
• Prepare terminated trials for warehousing.
• Other duties as assigned.

Work Environment

The role will be based in an office setting. The position supports one of the largest oncology clinical research sites in the world, offering a significant opportunity for career growth and development.