Senior Research Data Coordinator

The primary purpose of the position is to provide data coordination for all aspects of the conduct of clinical research studies for the Thoracic Head & Neck department’s research program.

DATA MANAGEMENT
* Abstracts and collects patient data from electronic health records and other relevant source documents.
* Ensures 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.
* Performs ongoing and concurrent review of data to ensure completeness and accuracy; addresses data entry omissions or inconsistencies and amends errors in a timely manner.
* Assists in database coordination, build, and maintenance for all IIT/IND studies that are utilizing an institutional database.
* Develops and maintains systems for controlling data flow; develops spreadsheets or other tracking tools for data that cannot be entered into a database.
* Provides data for study progress and patient safety reports, such as IRB continuing reviews.
* Creates accrual and/or toxicity reports as needed; assists in the collection and evaluation of protocol data and compiles protocol data for statistical review/manuscript submission.
* Utilizes different institutional databases to obtain and verify patient and protocol information including, but not limited to, PDMS, CORe, PDOL, and the EHR(OneConnect [Epic]).
* Assist internal/external staff with the creation of new user accounts and database support on assigned studies.
* Follows and adheres to national/state, institutional, departmental, and sponsor guidelines to accomplish and complete daily work assignments.
* Prepares reports for the sponsoring agency, as specified by reporting requirements (e.g., monthly, quarterly, semiannually, and annually).
* Prepare protocols for close-out visits and termination.

CLINICAL TRIALS COORDINATION
* Consults with principal investigator and other department personnel verbally, in handwritten notes or via keyboard on computer regarding ongoing studies; requires ability to gather information and determine the appropriate information to report.
* Participates in protocol site initiation/logistics meetings and attends departmental or institutional research meetings as well as approved off-site meetings or conferences.
* Processes requests for protocol-specific shipments of materials (supplies, specimens, etc.) and investigational agents.
* Submit request for image upload to sponsor vendor entities and follow up as necessary.
* Coordinate/communicate frequently with other research staff to identify and address any study-related issues, including but not limited to inadequate or missing source documentation, adverse event reporting and protocol deviations or violations.
* Develop templates/processes through communication with other research staff to ensure all information needed for data capture is documented.
* Inform research staff and others on upcoming deadlines to ensure data is completed.
* Acts as a liaison between the research team, sponsor, CROs, other institutions, and agencies to ensure data is captured accurately and appropriately.

ADMINISTRATIVE ACTIVITIES
* Maintains a level of professional expertise and credibility through attendance at both institutional and outside continuing education programs to keep current with research changes in regulations and policy.
* Tracks and manages all relevant protocol paperwork and essential documents in accordance with sponsor requirements and institutional policies and procedures.
* Demonstrates excellent oral and written communication skills when contacting other institutions and agencies (i.e., NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, computer-generated reports/emails and/or face to face.
* Coordinates and participates in monitoring visits and internal or external audits to ensure objectives are met.
* Creates, maintains, and provides status reports to departmental contracts and budgets team members to help facilitate appropriate study payment.
* Trains staff and others on data management, data entry, tracking, databases, and other tasks as needed.
* Educational presentations updating on new/revised process changes.
* Assists on assigned protocol audits; participate on site audits.
* Designs, implements, and reports on projects and project status.
* 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.