Research - Laboratory/Non-Laboratory, Staff/Administrative
Responsible for coordinating the clinical research program for two large research groups, the Burn Unit’s Clinical Research Program which consists of 3 sponsored clinical trials, the general plastic surgery research, two NIH-sponsored trials (non-burn protocols), and a Quality Assurance/Quality Improvement group. Assist with 4-5 high-profile vascularized composite allotransplantation programs. Work directly with the research manager, burn research nurse, and principal investigators to develop, amend, and execute study protocols. Assist with the education and guidance of numerous undergraduate and medical students, burn fellows, and residents in how to conduct clinical research and QA/QI projects at Johns Hopkins.
Coordinate the day-to-day activities of multiple clinical research studies, and assist with study design and in defining study goals.
Adhere to and maintain good working knowledge of assigned protocols, regulatory and reporting requirements. Maintain regulatory binder for each assigned protocol. Prepare and submit Institutional Review Board and Sponsor correspondences (e.g., continuing reviews, changes in research, adverse event reporting).
Identify and recruit study participants. Maintain recruitment. Verify participant eligibility for studies by comparing participant history and clinical laboratory results with protocol requirements. Monitor, schedule, and execute participant study visits, attend clinic as necessary, and maintain a research chart for each participant.
Design and create protocol‑specific case report forms, and assist less experienced staff in the design and creation of such forms.
Develop and maintain a system for tracking participant activity and financial management including invoicing. Provide written information for appropriate billing of sponsors to the Research Management Services staff. Advise of completed study activities to enable timely study payment / reimbursement from sponsors.
Collect, organize, enter, compile, analyze, and maintain clinical research data including imaging and bio-specimens. Ensure the accuracy, validity, and timeliness of all research data for use in presentations and publications. Advise on query design to obtain data using slicer-dicer and interacting with the DataTrust, and identify additional ways to obtain participant data in HIPAA-compliant ways to conduct research and improve clinical care.
Maintain meticulous study documentation and record-keeping.
Organize regulatory paperwork, and assist with manuscript preparation.
Assist in developing study budget and with invoice preparation.
Assist with the orientation and training of junior research staff in Institutional Review Board, protocol, clinical research information, Good Clinical Practices as it applies to research.
Assist with the education and guidance of undergraduate and medical students, burn fellows, and residents in how to conduct clinical research, protocol review, IRB application submission, quality assurance/quality improvement projects, and advice on how best to navigate the Hopkins research systems.
Assist the Principal Investigator in preparing for audits.
Meet regularly with Principal Investigator and other study team members regarding overall study progress, and participate in other meetings as required.
Perform miscellaneous related duties as assigned.
Bachelor’s degree in a related field required.
Three (3) years of related experience required.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 18 graduate degree credits (semester hours) 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.
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.
Classified title: Sr. Research Program Coordinator
Working title: Sr. Research Program Coordinator
Role/Level/Range: ACRP 37.5/E/04/MB
Starting Salary Range: $38,920.08 - $53,517.60 (commensurate with experience)
Employee group: Fulltime
Employee Status: Exempt
Schedule: Monday-Friday –8:30am-5:00pm 37.5hrs/Wk - Telecommuting to be determined by the supervisor. Will have to travel between E. Baltimore and Bayview campus.
Location: 550 N. Broadway, Baltimore, MD
Department name: 60009388-SOM PRS Research - Plastic and Reconstructive Surgery
Personnel area (School): SOM – 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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