Clinical Research Program Manager - Baltimore, United States - InsideHigherEd

Description

We are seeking a Clinical Research Program Coordinator who will work under the direction of and in collaboration with the Principal Investigator and other research leadership. This position will drive major programmatic initiatives in the Precision Medicine Center of Excellence (COE) for Kidney Disease, specifically for acute kidney injury and glomerulonephritis. The position requires strong project management and organizational skills, knowledge of clinical research regulations and grant processes, and the ability to work independently and with diverse collaborators and stakeholders. They will manage regulatory responsibilities, protocol implementation, and institutional relationships for a portfolio of ongoing and future studies conducted within the Division of Nephrology. This includes several ongoing multi-disciplinary and human translational research studies, multi-site longitudinal studies, and related sub-studies. In addition, this position will advise on and actively contribute to developing and implementing future studies and new clinical trials within the Center. The incumbent will work with JHU faculty and staff members of the nephrology clinical study team and will serve as a resource in a team environment, working in coordination with the Division of Nephrology administrative team.

Essential Job Functions

The person in this position will assist in the precision medicine program and multiple research projects. The role includes overseeing enrollment and data pipelines, quality control with samples, performing project analysis, preparing grants, recruiting participants for research studies, and occasionally conducting study visits. It is anticipated that 80% of the effort will be allocated to specific research projects, and the remaining 20% will be allocated toward divisional research operations. This allocation may be subject to change over time.

Specific Duties & Responsibilities

Leadership/Strategy

• Assist in developing project reports, forecasting resources, and grant proposals.
• Assist in new study development by assessing new protocols for clarity, thoroughness, feasibility, maintaining subject safety, and other considerations.
• Assist with orientation and oversight of less senior research staff and ensure research staff are appropriately trained.

Project Management

• 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).
• Prioritize kidney COE requirements based on estimated impact to users, implementation cost, and availability of existing solutions.
• Participate in designing and implementing complex data pipelines and work with the Associate Director and IT to develop project roadmaps and timelines.
• Perform project management duties to ensure that COE development progress aligns with the project roadmap and remains on schedule and within budget, from initial deployment plans through implementation.
• Communicate proactively with team members to encourage, identify problems, create solutions, and implement efficiency improvements to resolve project barriers.
• Provide oversight for adherence to institutional standards and guidelines for security, continuous service improvement, and customer service.

Administrative

• Collaborate with the Principal Investigator(s) and divisional administrators to oversee study budgets, contracts, invoice generation, and invoice payment.
• In collaboration with the Divisional Budget Analyst, assist with maintaining current subcontracts for other universities and participating centers and identify and develop new subcontracts for different universities and new satellite sites as needed. Also, assist with coordinating invoice payments and preparing and managing research budgets as required.
• Manage site agreements, IRB approvals, and budget development for new and ongoing studies in collaboration with study investigators.
• Interface with the Office of Research Administration, the Department of Medicine, the Technology Transfer Office, and other offices to manage contracts, data use agreements, material transfer agreements, and other relationships with external research collaborators.
• Collaborate with appropriate stakeholders, including the Associate Director and Principal Investigator(s), to create accurate and timely study progress reports and document study procedures, results, and conclusions.
• Develop documentation to help the kidney division with human resources issues, such as recruitment and onboarding of divisional research staff and standard operating procedures.
• Attend and participate in staff and division meetings, protocol and research-related meetings and training, performance improvement and quality assurance activities, and other meetings as required or assigned.
• Complete and maintain up-to-date documentation of human subject's research training for divisional faculty and staff as required by the JHM IRB and protocol Sponsors, including, but not limited to, JHM Research Compliance, HIPAA, Bloodborne Pathogens, and CPR.
• Other duties as assigned.

Special Knowledge, Skills, & Abilities

• Strong organizational skills, attention to detail, ability to work independently, excellent verbal and written communication skills, and strong interpersonal skills are necessary.
• Ability to handle multiple tasks at once and work well as a team member.

• Bachelors' Degree, preferably in health-related sciences.
• Requires minimum of five year's experience in clinical research at an academic, government, or pharmaceutical industry environment.
• Requires minimum of one year of management experience.
• Requires experience in clinical research and regulatory affairs.
• Experience in protocol and informed consent writing, data analysis, grant writing, and /or manuscript preparation required.
• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
  

• Related Master's or PhD degree preferred.
• Knowledge of SQL preferred.
• Experience in budget generation, contractual process and financial management of clinical trials preferred.

Classified Title: Clinical Research Program Manager
Role/Level/Range: ACRP/04/MD
Starting Salary Range: $55,200 - $96,600 Annually ($75,000 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: Monday- Friday 8:30am to 5pm
Exempt Status: Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM DOM Nephrology
Personnel area: School of Medicine