Under the direct supervision of the Clinical Research Program Manager or the Principal Investigator, we are seeking a Sr. 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 Sidney Kimmel Comprehensive Cancer Center Brain Cancer Program and Adult Brain Tumor Consortium (ABTC). The Sr. Research Program Coordinator is responsible for the organization, entry, maintenance and accuracy of all clinical research data for complex and detailed clinical trials and may assist with orientation of less senior research staff in protocol and clinical research information. This is an intermediate level position in managing clinical trials and/or registry databases within the research program.
Specific Duties & Responsibilities
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 and clinical data in medidata RAVE.
Maintains regulatory binder for each assigned protocol.
Prepares and submits annual renewal requests, amendments, and adverse event reports with clinical input according to CIRB, local 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.
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 ABTC Central office and/or the SKCCC Clinical Research Office and Oncology Information Systems and/or ABTC/CTSU.
Maintains an electronic 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 related discipline.
Three years related experience.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Special Knowledge, Skills & Abilities
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.
Classified Title: Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: Min $40,900 - Max $71,600 Annually ($56,250 budgeted; Commensurate with experience) Employee group: Full Time Schedule: M-F, 830-500 Exempt Status: Exempt Location: Hybrid/School of Medicine Campus Department name: SOM Onc Brain Cancer 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.edu/benefits-worklife/
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. 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.
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