Research - Laboratory/Non-Laboratory, Staff/Administrative
Johns Hopkins Clinical Research Office seeks a Research Program Coordinator who is responsible for dispersing, collecting and monitoring research information on multi-site studies managed by the SKCCC Clinical Research Office Coordinating Center. The Coordinator is responsible for all regulatory aspects of the research studies including JH eIRB submissions/amendments and maintaining regulatory documents for external sites. The candidate will report to the Coordinating Center Clinical Research Program Manager.
Specific Duties and Responsibilities:
Maintains good working knowledge of all assigned protocols and reporting requirements.
Works closely with external sites.
Distributes all protocol information (e.g., protocols, consent, amendments) to external sites and maintains an accurate distribution log.
Ensures external sites are following compliance standards.
Maintains regulatory binders for each assigned site.
Prepares IRB submissions as needed.
Ensure that external research staff maintain complete and accurate research data and charts on a real time basis and are well prepared for auditing and monitoring visits.
Meet regularly with study team to review overall study progress.
Organize and participate in site initiation visits for studies where the Johns Hopkins PI is managing the multi-site study.
Trains external staff on the use of CRMS.
Works closely with CRMS staff to develop Case Report Forms and study calendars.
Ensure SKCCC Standard Operating Procedures are in practice.
Assists the Principal Investigator or Program Manager in the orientation of external site staff in trial management procedures.
Works with external sites for central registration of all study participants in multi-site trials.
Provides education to research staff about coordinating center standards and gives one-on-one guidance to staff in following coordinating centers SOP's.
Ensures that coordinating center standards for performance of clinical trials at multiple sites are adhered to.
Ensures system for generation, tracking, and resolution of data queries is adhered to.
Provides management oversight of centralized system of data entry for multiple clinical research sites, including databases, spreadsheets, case report forms, and research chart standards.
Coordinates and conducts audits, monitoring visits and inspections at all participating sites. Prepares reports for audit and monitoring results. Notifies appropriate authorities of major violations.
Is knowledgeable of and complies with ICH Good Clinical Practice, IRB, and NCI Coordinating Center policies and procedures.
Minimum Qualifications (Mandatory):
Bachelor's Degree in related discipline preferred.
Some related experience required.
Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency Formula.
Certification as a Clinical Research Professional is preferred.
Special Knowledge, Skills, and Abilities:
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.
Ability to manage multiple and competing priorities.
Knowledge of clinical research practices and principles required.
Must have excellent time management skills.
Must have excellent oral and written communication skills.
Classified Title: Research Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.26 - $22.35/hr (commensurate with experience) Employee group: Full Time Schedule: M-F 8am- 4:30pm Exempt Status: Non-Exempt Location: School of Medicine Campus Department name: SOM Onc Clinical Research Office Personnel area: School of Medicine
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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