Senior Research Program Coordinator II
The Department of Oncology, Cancer Immunology, is seeking a full time Sr. Research Program Coordinator II (Sr RPC II). Under the limited supervision of the Clinical Research Program Manager, the Sr. RPC II will be responsible for coordinating the clinical course and research activities of the research program at Johns Hopkins. Position will oversee all facets of research activities, data management and regulatory activities for research projects. Responsible for monitoring progress of research protocols for institutional and multi-center studies; will work on several assigned research protocols simultaneously. Works on complex clinical studies, which require a high level of knowledge, coordination and data abstraction. Research protocols will vary in length, complexity, procedures required, number of subjects to enroll, investigator and site. Assist with orientation of less senior research staff in protocol and clinical research information.
DUTIES AND RESPONSIBILITIES
- Consent and enroll patients into investigator-initiated and multi-site studies.
- 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.
- Coordinate patient visits, collection of data, record maintenance, and regulatory documentation. Responsible for the collection and accuracy of data during each patient visit. Adheres to all protocol requirements to ensure the validity of clinical research subject data. Determine and report any abnormal symptoms of patient, including abnormal readings during procedures.
- Responsible for the organization, entry, maintenance, and accuracy of all patient clinical research data for complex and detailed studies. 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.
- Perform the following procedures for studies: collect and process samples (e.g., blood, urine, and tissue) and coordinate any procedures (i.e. x-rays, etc.) and others per protocols.
- Work with the research pharmacy with coordinating the dispensing of investigational drugs (if required).
- Maintains regulatory binder for each assigned protocol. Prepares and submits annual renewal requests, amendments, adverse event reports, etc., according to IRB and other institutional and sponsor requirements.
- May assist the principal investigator and/or program manager in defining information and plans required to accomplish goals of studies, including design of standard operating procedures. Will design and create protocol‑ specific case report forms as needed. May also assist less experienced staff in design and creation of such forms.
- Meets regularly with study team 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 research account/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 databases, 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. Attend site visits throughout the course of the study with pharmaceutical representatives. On occasion, will prepare for and attend internal, sponsor, FDA, OSHA, OHRP or JCAHO inspections/audits.
- Assist in writing abstracts and manuscripts for different studies.
- Completes minimum requirement for continuing educational units. Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and SKCCC Clinical Research Office policies.
BA/BS degree in Biological/Social Sciences or other appropriate discipline and five (5) years related experience required. Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula. Additional graduate level course work preferred.
Special Knowledge, Skills, or Abilities / Competencies:
- 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
JHU Equivalency Formula: 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.
Salary:$43,871 - $60,402
Work Schedule/Hours: Monday-Friday/8:30-5:00p/37.5 hrs
Location: East Baltimore Campus
The successful candidate(s) for this position will be subject to a pre-employment background check.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at email@example.com. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
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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