Under the direction of and in collaboration with the Principal Investigator and other Center leadership, this position will be responsible for the overall management of regulatory responsibilities, institutional relationships, and protocol implementation for a portfolio of ongoing and future studies conducted within the Division of Rheumatology’s Lyme Disease Research Center (LDRC), located at Johns Hopkins at Green Spring Station. This includes several ongoing multi-disciplinary and human translational research studies with associated sample biorepositories, specifically a multi-site longitudinal study, a clinical case series, and several smaller, related sub-studies. In addition, this position will advise on and actively contribute to the development and implementation of new protocols within the Center, including a possible clinical trial. The incumbent will work with JHU faculty and staff members of the LDRC clinical study team, as well as adult research participants as needed, and will serve as a resource in a team environment working in coordination with the Division of Rheumatology administrative team, the IRB, the SOM Office of Research Administration, the Office of Technology Ventures, and other internal and external collaborators.
Specific Duties & Responsibilities
Manage regulatory compliance within the LDRC, including: assisting with generation of initial study submissions and overseeing approval process; maintaining regulatory binders for all studies; preparing and submitting annual continuing reviews, amendments, adverse event reports, etc., according to IRB and other institutional requirements; preparing for and participating in monitoring visits; ensuring study team trainings are completed and current; managing IRB-related study communications; and any other IRB-related or regulatory issues that arise.
Maintain knowledge of study protocols and reporting requirements for all studies, and follow current federal, state and institutional laws and guidelines to access and maintain confidential records related to research participant health information. Ensure compliance with institutional policies and good clinical practices regarding both clinical study visits and biorepository management. Serve as an internal and external resource in a team environment and mentor junior research coordinator(s).
With input from LDRC leadership, create, submit, and manage approval of Material Transfer Agreements with internal and external academic and non-academic collaborators to the Technology Ventures Office, and ensure timely processing to facilitate research collaborations with other institutions.
With input from LDRC leadership, create and manage Data Use Agreements with internal and external academic and non-academic collaborators, as needed.
Assist the Principal Investigator and other co-Investigators in communications with ORA for contracting, agreements, and managing relationships with internal and external collaborators.
In collaboration with the Divisional Budget Analyst, assist with maintaining current subcontracts for other universities and participating centers, and assist with identification and development of new subcontracts for other universities and new satellite sites as needed. Also assist with coordinating payment of invoices, and preparing and managing research budgets as needed.
Serve as a resource to and liaison between JHU and three existing satellite sites. Meet with the research team at JHU and at Mid-Atlantic satellite sites as needed, and facilitate regular communication to provide oversight and guidance in protocol implementation and adherence, recruitment methods, and to review study progress.
Create new, disseminate, and update existing standard operating procedures to ensure accuracy of data collection during participant study visits. Assist with orientation and oversight of less senior research staff and ensure research staff are properly trained.
Oversee resolution of issues related to research participant billing, as needed. Ensure study PRAs are accurate and advise the PI and research staff as necessary.
Assist PI and LDRC research team with new study development, including: reviewing and assessing new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety etc. If required, advise on clinical trial registration, appropriate staffing and resource needs, and coordination with research pharmacy.
Attend and contribute to weekly LDRC scientific and research operations team meetings at Green Spring Station and/or Bayview Medical Center. Participate in Rheumatology Division staff meetings and LDRC meetings related to biorepository management at Bayview Medical Center. Travel to satellite research sites in the Mid-Atlantic region as needed for meetings, site visits, establishing recruitment networks, etc.
Serve as a back-up for conducting participant study visits, especially during peak enrollment periods, when additional coverage is required, or as needed due to Center research study portfolio expansion.
Other duties as assigned.
Bachelor's degree in related discipline. Five years related experience. Knowledge of and experience with clinical research practices and principles, specifically regulatory affairs, is required. Strong organizational skills, high attention to detail, ability to work proactively and independently, and strong interpersonal skills are a must. Must be experienced in handling multiple tasks at once, and working well as a member of a team. A working knowledge of computers, including proficiency in Microsoft Office, especially Excel and Word is required.
Related Master's degree preferred. Certification as a Clinical Research Professional preferred. Experience with material transfer agreements, data use agreements, and other contracting activities through JHU preferred. Experience managing or coordinating multi-site cohort studies preferred.
Special Knowledge, Skills, and Abilities
Physical requirements for the job:
Sitting in normal seated position for extended periods of time. Ability to use a keyboard and move about. Ability to see and hear within normal parameters.
Supervisory responsibility: This position will share supervisory responsibility of a Senior Research Program Coordinator with Senior Data Management staff.
Classified Title: Clinical Research Program Manager Working Title: Clinical Research Program Manager Role/Level/Range: ACRP/04/MD Starting Salary Range: $52,495 - 72,210; Commensurate with Experience Employee group: Full Time Schedule: Monday - Friday, 8:30am-5:00pm / 37.5 hours per week Exempt Status: Exempt Location: 33-MD:Johns Hopkins Bayview Department name: 10002797-SOM DOM Bay Rheumatology Personnel area: School of Medicine
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