Under the direct supervision of the Program Manager or the Principal Investigator, we are seeking a Research Program Coordinator who will be responsible for monitoring the clinical course and collection of research data on patients entered onto research protocols at the Johns Hopkins University. The Research Program Coordinator is responsible for the organization, data entry, maintenance and accuracy of all patient clinical research data in a timely and ongoing manner. These data will be used to generate specific study findings after the data is analyzed.

Specific Duties & Responsibilities

• Maintains good working knowledge of all assigned protocols and reporting requirements. Transmits and distributes protocol information. Responsible for submission, verification, and maintenance of protocol specific information for the department.
• Maintains regulatory e-binder for each assigned protocol. With assistance, 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 program manager in defining information and plans required to accomplish goals of studies. May help design 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 enrollment and relevant data points in databases for the Radiation Oncology department.
• Maintains a research chart for each patient (electronic and paper). 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, Research Program Manager, Research Nurse, and Principal Investigator to review data accuracy and overall study progress.
• Works with the Clinical Trials staff to ensure proper coordination and management of research studies.
• Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial requirements.
• Prepares reports on individual patients as required by the principal investigators and/or external agencies. Enters patient demographic and clinical data into institutional databases as required. Responds in a timely manner to special projects or queries related to study data.
• Prepares for and participates in monitoring and audits of studies. Corrects errors in database when necessary.
• Completes all required research trainings in order to work on a study team.
• Has working knowledge of and complies with Departmental, Johns Hopkins SKCCC, and School of Medicine.

Special Knowledge, Skills, & Abilities

• Excellent organizational skills required.
• Excellent attention to detail skills required.
• Ability to follow multiple, detailed directions of various protocols.
• Knowledge of medical terminology highly desired.
• Must have excellent time management skills.
• Must have excellent oral and written communication skills.
• Must have excellent computer skills and experience.

Specific Requirements

• Must adhere to guidelines regarding honest reporting of sensitive and confidential patient information.
• Understands the importance/impact of data integrity in terms of patients, study results, costs, quality of service and scientific research in general.
• Regular contact with physicians, other health care personnel and occasionally, patients, requires the use of good judgment, tact and sensitivity.

• Bachelor's Degree in related discipline.
• Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
• Complete proficiency in the use of standard software applications, databases, spreadsheets and word processing (MS Windows, Excel, Word, etc.)
  

• Work experience in a clinical area or laboratory.

• Outstanding computer skills. Experience using REDCap is highly preferred.
• Experience using EPIC or other electronic medical record system is highly preferred.
• Eligibility for certification by a professional clinical research organization is preferred.

Classified Title: Research Program Coordinator 
Role/Level/Range: ACRO40/E/03/CD  
Starting Salary Range: $17.20 - $30.30 HRLY ($41,000 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F, 8:30am-5:00pm 
Exempt Status: Non-Exempt 
Location: School of Medicine Campus 
Department name: ​​​​​​​SOM Rad Onc Clinical Trials Group  
Personnel area: School of Medicine