The Research Program Coordinator will be responsible for coordinating clinical research activities, including data management, maintaining IRB documents and carrying out day to day activities of clinical research projects at the Johns Hopkins Parkinson's Disease and Movement Disorder Center. This will include pharmaceutical sponsored research and investigator-initiated research. The coordinator is responsible for monitoring progress of research protocols and collection of research data on patients entered into research protocols.
Specific duties & responsibilities:
This research position will coordinate and supervise the day-to-day clinical research operations which include:
· Assisting the Principal Investigator in developing and implementing study operating procedures related to recruitment, retention, study visits and specimen bank while ensuring that quality control procedures are adhered to.
· Coordinates the management of activities related to the pre-award and post award sponsored research projects according to established departmental and IRB process, including new and renewal funding submissions. This includes preparing new IRB protocols, annual renewal requests, and amendments with clinical input according to IRB for submission by the PI.
· Responsible for subject recruitment; obtaining informed consent of eligible study participants.
· Responsible for timely study-related communications via email or Teams with PI and other collaborators during business hours.
· Responsible for the organization, entry, maintenance, and accuracy of all patient clinical research data in a timely and ongoing manner. Also responsible for preparing necessary paperwork packets for study visits and data entry into standardized computer programs including specially designed web-based programs as well as internal databases.
· Maintains good working knowledge of all assigned protocols, maintains regulatory binder for each assigned protocol, verifies patient eligibility for studies, and meets regularly with principal investigators and supervisor of studies for review data accuracy and overall progress.
· Completing and maintaining the appropriate HIPAA and Human Subjects Certifications and performing the informed consent process with potential study participants.
· Assist in conducting study research visit in the Johns Hopkins Outpatient Center, Radiology Center, Phipps or Meyer buildingds, or other venue on the East Baltimore campus.
· Coordination of invoicing and payments related to the Cores and grants, vendor set up and payments, approved staff reimbursements and travel reports.
· Assists Principal Investigators and Research Service Analyst in identifying and resolving compliance issues for sponsored research.
Minimum qualifications (mandatory):
Requires bachelor's degree in related discipline, and some experience.
Previous work on clinical trials in adults.
Experience with regulatory / IRB work and budget management and invoicing helpful.
Special knowledge, skills, and abilities:
Experience with electronic data capture.
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: 10003519-SOM Neuro Movement Disorders 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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