Sr. Research Program Coordinator

The Division of Behavioral Medicine is seeking a Sr. Research Program Coordinator to coordinate the implementation of two or more research protocols, as well as ongoing administrative processes related to multiple clinical research studies. The Senior Research Program Coordinator will be responsible for monitoring multiple study protocols for regulatory compliance and will assist PIs in completing regulatory reports such as investigational new drug applications and IRB applications, and data safety and monitoring reports. The SRPC will directly supervise at least on full-time staff and multiple work study students. SRPC will also help screen and enroll research subjects for complex multisite clinical study and provide continued monitoring, ensuring that all protocols are followed, and status reporting, billing, and other regulatory components are performed correctly.

The Senior Research Program Coordinator position involves working directly with research subjects to systematically conduct standardized psychophysical, electrophysical, behavioral, and psychological assessments and maintain records of testing. A variety of computer-controlled laboratory sensory testing devices will be used, including thermal sensory analyzers, algometers, von frey filaments, cold water baths, etc. This position will also involve coordination with other staff to ensure these tests are conducted at specific time points and will involve using this equipment to study human subjects at least 50% of the time.

Specific Duties & Responsibilities

• Supervises at least one full-time staff member and multiple work study students.
• Monitoring multiple study protocols for regulatory compliance and will assist PIs in completing regulatory reports such as investigational new drug applications and IRB applications, and data safety and monitoring reports.
• Telephone screening candidates to determine the eligibility of potential volunteers for a project.
• Coordinate staff and resources required for study procedures. Ensure completion of interventions, study measures, and instruments.
• Responsible for recruitment of subjects and implementing recruitment procedures.
• Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements. Confirms patient registrations and relevant data points in databases.
• Explain the study procedure to participants and obtain informed consent.
• Use software to manage, track, and report the flow of subjects through protocols.
• Handle relevant subject biological specimens and follow protocol requirements.
• Verify the scheduling of patient appointments, tests, and follow-up visits at the appropriate time in the treatment cycle to ensure the completion of protocol requirements. Schedule transportation for study volunteers' visits as needed.
• Design and compile materials, which aid Investigators/other staff in complying with protocol requirements.
• Conduct standardized psychophysical, electrophysical, behavioral, and psychological assessments and maintain records of testing.
• Check for accuracy and ensure proper storage of data. Ensure timely data entry.
• Work closely with the data manager to assist in quality control procedures.
• Assists with regulatory work across studies, including IRB, DSMB, ClinicalTrials.gov, and other required submissions and reporting.
• Assists with preparation for monitoring and audits of studies; may correct errors in the database when necessary and write responses to audit reports with input from the Principal Investigator.
• Prepare and distribute summary reports for research meetings as scheduled.
• Coordinate and notify study team members of study meetings and tasks needing completion.
• Will design and create protocol-specific case report forms as needed.
• Coordinates research protocols with investigators and external research colleagues for multisite studies.
• Maintains good working knowledge of all assigned protocols and reporting requirements.
• Works on complex clinical studies, which require a high level of knowledge, coordination, and data abstraction.
• Perform administrative and clerical tasks as needed, including ordering supplies.
• Involves frequent/regular contact with research subjects and a variety of medical professionals.

• Bachelor's Degree in related discipline.
  

• Three years related research experience.

• Advance Degree related to research MA/MS or PHD.

Classified Title: Sr. Research Program Coordinator
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $41,300 - $72,300 Annually ($56,800 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: M-F 8:30am - 5pm
Exempt Status:Exempt
Location:Johns Hopkins Bayview
Department name: SOM Psy Behavioral Medicine
Personnel area: School of Medicine