Research - Laboratory/Non-Laboratory, Staff/Administrative
Under the direct supervision of the Research Nurse Manager or the Principal Investigator, the Sr. Research Program Coordinator is responsible for monitoring the clinical course and collecting research data on patients entered onto research protocols at the Sidney Kimmel Comprehensive Cancer Center and participating sites. 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 the orientation of less senior research staff in protocol and clinical research information. This is an intermediate level position in managing clinical trials and registry databases within the research program.
Specific Duties and Responsibilities:
Maintains an excellent working knowledge of all assigned protocols and reporting requirements.
Works on complex clinical studies, which require a high level of expertise, 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 program manager in defining information and plans required to accomplish studies' goals.
Will design and create protocol‑ specific case report forms as needed.
May also assist less experienced staff in the design and creation of such documents.
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 information for the physician in treatment planning, presentations, and publications.
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 external agencies.
Enters patient demographic and clinical data into the institutional database as needed.
Timely response to particular projects or queries related to the data.
Prepares for and participates in monitoring and audits of studies.
Corrects errors in the database when necessary.
Writes responses to audit reports with input from the Principal Investigator.
Completes minimum requirements for continuing education units.
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 procedures.
BA/BS degree in Biological/Social Sciences or other appropriate discipline required.
Minimum three years of experience in complex and detailed clinical trials/medical research required.
Proficiency in the use of software applications, databases, spreadsheets, and word processing required.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits 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:
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 trail 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 good judgment, tact, and sensitivity.
This description is a general statement of required primary duties and responsibilities performed regularly by the incumbent(s). It should not 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/04/MB Starting Salary Range: $38,920-$53,520 (commensurate with experience) Employee group: Full Time Schedule: Monday-Friday/8:30am-5:00pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10002938-SOM Onc Upper Aerodigestive Cancer Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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