Responsibilities/Duties:

The primary role of this position is to oversee and manage clinical trial registrations and results reporting to the National Institutes of Health’s ClinicalTrials.gov (CT.gov) and the National Cancer Institute’s Clinical Trials Reporting Program (CTRP) in compliance with federal and institutional requirements. This position will support all Masonic Cancer Center trials and will be a part of Cancer Research Translational Initiative’s Data Solutions Group (DSG).  This position will work closely with Data Management Associates (DMAs) within DSG, Cancer Informatics team (CISS), Clinical Trials Office (CTO), investigators and other stakeholders. 

The CT.Gov/CTRP Reporting Coordinator will report directly to Scientific Director- Cancer Research Translational Initiative (CRTI).

The CT.Gov/CTRP Reporting Coordinator will be responsible for

• Registering and reporting trials to CT.Gov (35%)
• Registering and reporting trials to CTRP (35%)
• Manage Data Review Meetings (25%)
• Other data administrative tasks (5%)

The CT.Gov/CTRP Reporting Coordinator will perform the following functions, ensure compliance and will serve as a Subject Matter Expert (SME).

• Identify qualifying investigator initiated trials (IITs) in the startup phase and register the trials with CT.Gov.
• Work with study investigator and biostatistician to report trial results to CT.Gov.
• Communicate and work with clinical research team within the University and develop a process for notifying DSG of all cancer studies meeting requirements for federal reporting.
• Attend meetings related to CT.Gov and make necessary changes to DSG processes to maintain compliance.
• Attend seminars and training sessions that pertain to data management to share any changes in policies and procedures.
• Communicate and coordinate data reporting activities with different stakeholders and maintain compliance.
• Work closely with the CTO and CISS on functions that pertain to federal reporting requirements. Ensure data generated by the National Cancer Institute is accurate and aligns with that generated by Masonic Cancer Center.
• Participate in CTgov/CTRP user monthly teleconferences.
• Assist with regular quarterly accrual maintenance for CTRP. Pull and deliver updated status reports to the CTRP registrar.
• Develop and revise standard operating procedures related to the work scope covered by the position.
• Work closely with DMAs and manage Data Review Meetings for DSG studies as needed.
• Participate in various meetings and working groups within Masonic Cancer Center.
• Identify problems and trends involving trial registrations and results reporting and develop and implement appropriate responses.
• Collaborate with CISS involving various trial search tools utilized by Masonic Cancer Center, e.g. Via Oncology, Study Information Portal (SIP), and other projects as assigned.
• Other taskts as assigned.

Contacts:
• Department:
     o Regular contact with supervisor, protocol review and monitoring committee manager, OnCore database administrators, and other administrative staff.
• University:
     o Contact with physicians, investigators, biostatisticians, research nurses/CRC, regulatory and data coordinators, Cancer Informatics team, IRBs, and other departmental personnel involved in and/or assisting with research. Contact with university technology staff to maintain workflow.
• External:
     o Contact with the National Cancer Institute, Food and Drug Administration, pharmaceutical sponsors, national and international cancer research Cooperative Groups, OnCore CTMS Enterprise Research System, and representatives from other institutions and organizations to exchange information.

This position cannot provide visa sponsorship.

All required qualifications must be documented on application materials.

Required Qualifications:
• Bachelor’s degree in science or work experience to equal four years in an area related to this position
• Proven excellence in oral and written communication skills
• Excellent customer service skills
• Excellent work ethic and teamwork skills
• Strong organizational skills
• Extensive computer experience in Microsoft Office

Preferred Qualifications:
• Prior experience in an academic or clinical research setting
• Knowledge of GCP, medical and/or clinical trial terminology
• Experience with data collection, analysis and reporting
• Experience reading and following research protocols
• Experience using OnCore, Clinical Trial Management System