Under the supervision of the Brain Injury OutcomeS (BIOS) Division Manager (Department of Neurology), the Research Program Coordinator will coordinate several clinical studies. Dotted report line to the individual research PIs. The position will coordinate the implementation of research protocols as well as ongoing administrative processes related to these studies; screen and enroll patients, and provide continued monitoring of these studies ensuring that all protocols are followed and status reporting, billing, and other regulatory components are performed correctly. Responsibilities include the recruitment of patients throughout the Johns Hopkins Clinical Research Network, performance of patient assessments in ED, neuro-ICU, stroke unit, rehabilitation unit, etc. Candidate will also cross-train and serve as back-up to other BIOS coordinator(s).
Specific duties & responsibilities:
Provide support and coordination for fellows and physicians during ongoing clinical studies. This would include study start up training and documentation, protocol, consent, enrollment, study completion and post study closure.
Accountable for the overall administration and outcomes for trials requiring advanced-level knowledge and skills to manage a diverse portfolio of research responsibilities.
Daily screening, recruitment, protocol adherence, schedule patient visits and assessments, as well as telephone follow up.
Write and submit to the Institutional Review Board protocols, consent forms, amendments and continuing reviews as needed.
Perform noninvasive tests, including measuring blood pressure and operating investigative diagnostic device(s).
Recruit research subjects, including screening phone calls or visits as needed.
Coordinate participation of subjects, including providing stipend, parking, and public transportation compensation for their participation.
Regular attendance at research meetings as well as providing updates on the study progress and issues related to the research.
Prepare and maintain individual participant study binders.
Adhere to FDA regulatory compliance and regulations.
Utilize good clinical research practices.
Maintain detailed working knowledge of protocols.
Maintain appropriate correspondence with the IRB. Complete and submit IRB Change in Research Reports, including adverse events, protocol deviations and protocol amendments.
Complete and submit annual IRB continuing review reports.
Ensure quality, consistency, and accuracy in the conduct of research trials.
Maintain the research data base including data entry.
Respond in a timely manner to special projects or queries related to the data.
Assist with consenting study participants and documenting the consent process.
Assist in data collection including patient contact for enrollment and follow-up.
Oversee record management to include but not limited to set up database, as well as processing systems and efficiencies for reporting purposes using Excel, Access, or similar systems
Participate in conference calls and meetings with the investigators for discussions about the projects.
Conduct all study close out related procedures including IRB termination reports
Minimum qualifications (mandatory):
Bachelor's degree in related field
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.
JHU Equivalency Formula:
30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience.
Additional related experience may substitute for the required 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.
2 years’ experience in clinical or medical research setting strongly preferred. Knowledge of medical terminology, clinical research practices and principles (GCPs) is strongly preferred.
Experience and familiarity with EPIC and electronic data capture systems is strongly preferred. Previous experience in the clinical environment, patient recruitment and patient approach is strongly preferred.
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: 10003520-SOM Neuro BIOS 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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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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