Sr. Research Program Coordinator

• Maintains good working knowledge of all assigned protocols 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 program manager in defining information and plans required to accomplish goals of studies.
• Will design and create protocol‑ specific case report forms as needed.
• May also assist less experienced staff in design and creation of such forms.
• 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, 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.
• Will develop and maintain a protocol database or spreadsheet for tracking patient activity, financial management and data analysis as needed.
• Will meet with clinical trial financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the Sponsor as defined in the financial contract.
• May participate in the development of invoicing schedules.
• 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.
• Writes responses to audit reports with input from the Principal Investigator.
• Completes minimum requirement for continuing educational units.
• Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and SKCCC Clinical Research Office policies.
• May instruct introductory level clinical research personnel in these guidelines and policies.

• Bachelor’s Degree in Biological/Social Sciences or other appropriate discipline required.
• Three (3) years of experience in complex and detailed clinical trials/medical research required.
• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

JHU Equivalency Formula:18 graduate degree credits (semester hours) may substitute for required of experience. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.

Preferred Qualifications:

• Additional graduate level course work or certification as a Clinical Research Professional is preferred.

Special Knowledge, Skills, and Abilities:

• Proficiency in the use of software applications, databases, spreadsheets, and word processing required.
• Excellent organizational skills required.
• Excellent attention to detail skills required.
• Knowledge of medical terminology required.
• Familiar with medical procedure and laboratory fees.
• Ability to manage multiple and competing priorities.
• Knowledge of clinical research practices and principles required.
• Ability to understand a clinical trial financial contract.
• Must have excellent time management skills.
• Must have excellent oral and written communication skills.