Research - Laboratory/Non-Laboratory, Staff/Administrative
Under direct supervision of the Director of the Pancreatic Cancer Center of Excellence at the Johns Hopkins University School of Medicine, the Sr. Research Program Coordinator is responsible for coordinating IRB submissions, protocol implementation, monitoring to ensure the collection of data for studies, and development and management of the Clinical, Genomic, Biospeciman databases. This is an intermediate level position in managing clinical trials and/or registry databases within the research program
Specific Duties and 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.
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 supervise 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. Develop and manage the Clinical, Genomic, Biospeciman databases.
Conduct the supervised researches on the Clinical, Genomic, Biospeciman databases and participate in the preparing the presentation and manuscript.
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.
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.
BA/BS required in Biological/Social Sciences, Biostatistics, Public Health or other appropriate discipline required.
Graduate level course work or certification as a Clinical Research Professional and/or in Biostatistics is preferred.
Requires a minimum of three years of related experience required.
Minimum two 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 graduate level courses may substitute for some work experience. Additional education may substitute for some experience, to the extent permitted by the JHU equivalency formula.
Excellent organizational skills required
Excellent attention to detail skills required
Knowledge of medical terminology required
Familiar with database management
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 the use of good judgment, tact and sensitivity.
Classified Title: Sr. Research Program Coordinator Working Title: Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $38,920 - $53,520; commensurate with experience Employee group: Full Time Schedule: M-F 8:30am- 5:00pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10002940-Cancer Immunology/GI Clinical Research 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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