Research Data Coordinator Melanoma Medical Oncology

The primary purpose of the Research Data Coordinator position is to provide data coordination for all aspects of the conduct of clinical research studies for the Melanoma Medical Oncology department’s research program.

The ideal candidate will have experience in managing clinical trial data and supporting research teams. Skilled in collecting and verifying patient information, maintaining accurate records, and preparing reports for regulatory and sponsor requirements. Strong ability to coordinate with investigators, staff, and external partners to ensure compliance and smooth study operations. Organized, detail-oriented, and committed to meeting deadlines and maintaining data quality.

What We Offer?
* Employer-paid medical coverage starting day one for employees working 30+ hours/week, plus optional group dental, vision, life, AD&D, and disability insurance.
* Accruals for PTO and Extended Illness Bank, plus paid holidays, wellness, childcare, and other leave options.
* Tuition Assistance Program after six months of service and access to extensive wellness, fitness, and employee resource groups.
* Defined-benefit pension through the Teachers Retirement System, voluntary retirement plans, and employer-paid life and reduced salary protection programs.

DATA MANAGEMENT:
* Abstracts and collects patient data from electronic health record 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, tracks 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 amend errors in a timely manner.
* 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, OnCore, CORe, and the EHR (OneConnect [Epic]).
* Assist CRA/monitor with 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.
* Assists on assigned protocol audits; participate on site audits.
* Designs, implements, and reports on projects and project status.
* Prepare continue review for survival follow up studies for submission to the IRB.
* 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. 

WORKING CONDITIONS: