Sr. Clinical Research Program Manager

The Division of Gastroenterology and Hepatology is seeking a Sr. Clinical Research Program Manager for the GI Clinical and Translational Research Unit (CTRU). This position will report to CTRU leadership and work in collaboration with multiple investigators in the division. The Sr. Clinical Research Program Manager will be responsible for ensuring regulatory compliance, managing the day-to-day research activities per SOP/best practices, supervising staff and working with investigators in the implementation of research studies, including multi-center trials. The Sr. Clinical Research Program Manager will also contribute to the strategic and programmatic development of the CTRU by assisting with budget planning, the effective utilization of resources, and development and implementation of Standard Operating Procedures (SOPs).

Specific Duties & Responsibilities

Project Management & Implementation

• Assist with development of SOPs for all research related activities and staff.
• Provide overall management of day-to-day research activities and staff.
• Prioritize and optimize staff effort on sponsored studies by regularly assessing changing workloads based on current and anticipated active study needs.
• Run and/or organizes internal and external meetings, collaborating among various GI groups, national research groups, national societies, non-profits, industry, and faculty members of other institutions.
• Assist the study Principal Investigator and other co-Investigators in communications with Johns Hopkins ORA for contracting, agreements, and managing relationships with internal and external collaborators.
• Assist PI and CTRU 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.
• Assist with the maintenance of a centralized listing of past, active, and future clinical research projects.
• Manage, support, coordinate and implement study specific tasks as required including recruitment, data collection, regulatory submissions and site coordination and training for multi-center projects where JH serves as the coordinating center.
• Develop and update/maintain study documents including protocols, amendments, case report forms, SOPs, lab manuals, training documents and regulatory materials for dissemination to study teams and 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.
• Perform other duties as assigned.

Regulatory

• Develop and implement a robust quality management system to ensure compliance.
• Manage and monitor adherence to local, state, federal entities, GCP, IRB and other applicable regulatory requirements for study team and satellite sites.
• Provide initial and continuing training to staff and track SOM required education requirements to maintain compliance.
• Supervise and assist staff as needed on IRB and FDA submissions to ensure compliance.
• Assist JHU faculty and fellows with basic IRB questions and connect them with the appropriate IRB personnel.
• Serve as the primary resource for all regulatory related matters.

Finance

• Coordinate with ORA in budget development with sponsors.
• In collaboration with the GI Finance team, assist with maintaining current subcontracts for subsites and development of subcontracts for new projects.
• Facilitate meetings with the GI Finance Team and investigators to review various sponsored research accounts to ensure balanced budgets, timely invoicing and proper effort allocation of research staff.

Supervisory Responsibilities

• Hire and supervise CTRU staff including research technologists, regulatory specialists, coordinators and nurses.
• Orient and train new research staff on Hopkins-specific workflow to include appropriate practical shadowing and field training.
• Provide continuing education and training including revisions/updates on regulatory policies, innovative research tools, general professional development and certifications (ACRP, SCORA) to maintain a highly skilled and dedicated research team.
• Serve as an internal and external resource in a team environment and mentor junior research coordinator(s).

Special Knowledge, Skills, & Abilities

• Excellent organizational skills.
• Excellent attention to detail skills.
• Excellent ability to manag