Classified title: Clinical Research Program Manager
Starting Salary Range: 50,956-70,095
Employee group: Full-Time
Employee subgroup: Exempt
Schedule: 37.5 hours per week; Monday-Friday 8:30-5:00
Location: Johns Hopkins Greenspring Station
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, protocol implementation, and institutional relationships 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, specifically a multi-site longitudinal study, a clinical case series, and related sub-studies. In addition, this position will advise on and actively contribute to the development and implementation of future study sites and 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.
Specific duties & responsibilities:
Manage regulatory compliance within the LDRC, including: assisting with generation of initial study submissions and overseeing approval process; adding new study sites; 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 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. Serve as an internal and external resource in a team environment and mentor junior research coordinator(s).
Serve as a resource to and liaison between JHU and two existing satellite sites. Meet with the research team at JHU and 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.
Coordinate research implementation and new study site start up with the PI and research team, including managing site agreements, IRB approvals, and budget development. Assist with training new study coordinators and other medical and research staff at new satellite sites in understanding and implementing the protocol. Organize initiation and ongoing site meetings, and ensure that all personnel are properly trained in study procedures and protocol requirements.
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.
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.
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.
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.
With input from LDRC leadership, create, submit, and mange Material Transfer Agreements with collaborators to the Technology Transfer Office, and ensure timely processing to facilitate research collaborations with other institutions.
Assist the Principal Investigator and other co-Investigators in communications with ORA for contracting, agreements, and managing relationships with internal and external collaborators.
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.
Attend and contribute to monthly LDRC scientific and research operations team meetings at Green Spring Station and/or Bayview Medical Center. Travel to existing and new satellite research sites in the region as needed for meetings, site visits, etc.
Other duties as assigned.
Minimum qualifications (mandatory):
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 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 managing or coordinating multi-site cohort studies preferred.
Any specific 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 (indicate the number and type of persons supervised by incumbent):
This position will share supervisory responsibility of a Research Program Coordinator with Senior Data Management staff.
Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130... years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Baltimore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.