Sr. Research Program Coordinator

We are seeking a Sr. Research Program Coordinator to work under the direct supervision of the Program Manager and the Hopkins Break Through Cancer (BTC) group.  Will be responsible for entry of clinical and research data into the BTC database as well as maintenance of this database. Responsible for the organization, entry, maintenance and accuracy of all patient clinical research data in a timely and ongoing manner. Data will be used to generate specific study findings after the data is analyzed.

Specific Duties & Responsibilities

• Maintains good working knowledge of all assigned fields and reporting requirements.
• Works on complex clinical studies which require a high level of knowledge, coordination, and data abstraction.
• Transmits and distributes protocol information.
• Responsible for submission, verification, and maintenance of protocol specific information on the SKCCC Research Protocol Library.
• Maintains regulatory binder for each assigned protocol.
• Prepares and submits annual renewal requests, amendments and adverse event reports with clinical input according to IRB and Sponsor requirements.
• Adheres to all protocol requirements to ensure the validity of the clinical research data.
• May assist the principal investigator and/or other program managers in defining information and plans required to accomplish goals of studies.
• Designs and create protocol specific data collection forms with assistance.
• Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.
• Confirms patient registrations and relevant data points in databases for the SKCCC Clinical Research Office and Oncology Information Systems.
• Maintains a research chart for each patient. Collects, enters and compiles clinical data from a variety of sources. Ensures accuracy and timeliness of data so that information may be used by the physician in treatment planning for individual patients, presentations and publication.
• Verifies scheduling of patient appointments, tests, and follow up visits at the appropriate time in the treatment cycle to ensure completion of protocol requirements.
• May design and compile materials which aid physicians/other staff in complying with protocol requirements for these visits and tests.
• Meets regularly with Principal Investigator, Research Nurse, and Research Program Manager to review data accuracy and overall study progress.
• Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial and Registry requirements.
• Develops and maintains a protocol database or spreadsheet for tracking patient activity and data submission to internal and/or external registries.
• Meets with clinical trial financial management staff to identify procedures, lab tests, and protocol events that require invoicing to the Sponsor as defined in the financial agreement.
• Prepares reports on individual patients or the study as required by the principal investigators and/or external agencies.
• Enters patient demographic and clinical data into institutional database as required. Responds in a timely manner to special projects or queries related to the data.
• Prepares for and participates in monitoring and audits of studies. Corrects errors in database when necessary.
• Completes minimum requirement for continuing educational units.
• Has working knowledge of and complies with Good Clinical Practices, ICH Guidelines and SKCCC Clinical Research Office policies.

• Bachelor's Degree in related discipline.
• Three years related experience.
• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

Classified Title: Sr. Research Program Coordinator 
Role/Level/Range: ACRP/03/MB  
Starting Salary Range: Min $40,900 - Max $71,600 Annually ($56,250 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F, 830a - 500p 
Exempt Status: Exempt 
Location: Hybrid/School of Medicine Campus 
Department name: ​​​​​​​SOM Onc Hematologic Malignancies  
Personnel area: School of Medicine 

Total Rewards
The referenced salary range is based on Johns Hopkins University’s good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu