Under the direct supervision of the Pediatric Neuromuscular Clinical Research Supervisor and the Principal Investigators, the Sr. Research Program Coordinator is responsible for monitoring the clinical course and collection of research data on patients entered onto research protocols. 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. The Sr. Research Program Coordinator will also have patient exposure and clinical responsibilities for assigned research protocols. This is an intermediate level position in managing clinical trials and/or registry databases within the Pediatric Neuromuscular Clinical Research Program.
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.
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 supervisor 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 Pediatric Neuromuscular Clinical Research Program.
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 Investigators, and Research Program Supervisor 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.
May assist clinicians/clinical research coordinators with patient screening, recruitment, and consenting.
May perform interviews, complete structured tests, and collect pertinent data with potential/active research participants in the clinic.
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 a related discipline required.
Three (3) years related experience 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 one year 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.
Special Knowledge, Skills, and Abilities:
Experience 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.
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.
This description is a general statement of required major duties and responsibilities performed on a regular and consistent basis by the incumbent(s).
It should not be held to exclude other duties not mentioned that are similar in nature and level of difficulty.
Classified title: Sr. Research Program Coordinator
Working title: Sr. Research Program Coordinator
Role/Level/Range: ACRP 37.5/E/03/MB
Starting Salary Range: $38,920.08 - $53,517.60 (commensurate with experience)
Employee group: Fulltime
Employee Status: Exempt
Schedule: Monday-Friday –8:30am-5:00pm 37.5hrs/Wk
Location: Rubenstein 2146 - 200 N. Wolfe Street, Baltimore, MD
Department name: 10003526-SOM Neuro Pediatric Neurology
Personnel area (School): SOM – School of Medicine
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