Under the supervision of the Clinical Research Manager, the Research Program Coordinator is responsible for coordinating the research activities, data management, and regulatory activities for research projects as assigned. Will be responsible for complex clinical trials which require a high level of knowledge, coordination, and data abstraction. Responsibilities will also include coordination and support of numerous cooperative group affiliates. Will assist with orientation of less senior research staff in all areas of clinical research, including protocol information published by specific cooperative groups and by federal agencies. Will assist with general operations of the program.
Specific Duties and Responsibilities:
Coordinate assigned protocols, including patient enrollment, data abstraction, case report form completion and submission, specimen shipping, and other protocol-related tasks.
Interact with principal investigators and nurses as required by the protocols, providing support and protocol updates as required.
Work with the research pharmacy to facilitate patient orders, drug shipment, and drug data sheet updates.
Maintain electronic regulatory files and standard medical research charts for trial patients.
Attain a high level of expertise in institutional databases including EPIC, CRMS, eIRB. Organize and lead study initiation meetings with principal investigators and staff. Review and analyze new studies for difficulties that may arise with study processes and procedures. Suggest appropriate alternatives to possible complications.
Participate in staff meetings as a lead coordinator, preparing study progress reports for discussion, creating agendas, and scheduling space as needed.
Assist the Research Manager with program operations – providing suggestions for improved procedures, creating checklists and SOPs.
Coordinate audits, assisting with preparation, scheduling, and chart pre-review.
Some national travel may be required to attend study program-related meetings.
Complete minimum requirements for continuing education units.
Maintain up-to-date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and JHM IRB policies.
Screen, consent, and enroll study participants.Monitor participants during visits, perform data collection, quality assurance checks for data completion. Schedule participants, laboratory tests, medical examinations and consultations as needed per study protocol. Maintain accurate information on each study participant. Conduct telephone and in-person interviews following all protocol and HIPAA rules.
May also perform laboratory specimen processing, storage and shipment using approved biosafety procedures.
Perform miscellaneous related duties as assigned.
Minimum Qualifications (mandatory):
Bachelor's degree in a related discipline.
Some related experience.
Additional education may substitute for required experience, and additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Clinical research experience.
Experience using REDCap and/or other electronic data capture systems.
Experience using Microsoft Word and Excel.
Experience working with electronic medical records.
Special Knowledge, Skills, and Abilities:
Proficiency in the use of software applications, databases, spreadsheets, and word processing. Independent thinker and problem solver.
Attention to detail.
Good verbal and written communication skills.
Professional attitude and mature outlook.
Able to work independently to complete tasks and to work well with others.
JHU Equivalency Formula:30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Experience can qualify for education on the same basis. 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.
Classified Title: Research Program Coordinator Working Title: Research Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.26 - $22.35 Employee group: Full Time Schedule: M-F, 8:30 am - 5:00 pm Exempt Status: Non-Exempt Location: 04-MD:School of Medicine Campus Department name: 60009388-SOM PRS Research Personnel area: School of Medicine
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