Clinical Research Program Manager

2 days ago

Baltimore, Maryland, United States InsideHigherEd Full time
Job Title: Sr. Clinical Research Program Manager

The Division of Gastroenterology and Hepatology is seeking a highly skilled and experienced Sr. Clinical Research Program Manager to join our team. This is a unique opportunity to work in a dynamic and collaborative environment, contributing to the strategic and programmatic development of the GI Clinical and Translational Research Unit (CTRU).

Key Responsibilities:
  • Ensure regulatory compliance and manage day-to-day research activities per SOP/best practices.
  • Supervise staff and work with investigators in the implementation of research studies, including multi-center trials.
  • Contribute to the strategic and programmatic development of the CTRU by assisting with budget planning, resource utilization, and 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 organize 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, including 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 manage multiple and competing priorities.
    • Excellent time management skills, with demonstrated ability for self-direction and initiation.
    • Strong oral and written communication skills, and ability to work independently.
    • Demonstrated ability to work well with other professionals with minimal supervision and be comfortable being part of a diverse professional team.
    Minimum Qualifications:
    • Bachelor's Degree in health-related sciences or related discipline.
    • Eight years related experience in clinical research at an academic, government, or pharmaceutical industry environment.
    • Requires minimum of two years 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.
    • Requires experience in managing or coordinating multi-site cohort studies and/or clinical trials.
    • Requires experience in clinical research and regulatory affairs, including FDA-regulated trials (IND/IDE).
    • Additional education may substitute for experience to the extent permitted by the JHU equivalency formula.
    Preferred Qualifications:
    • Certification as a Clinical Research Professional preferred.
    • Experience in budget generation, contractual process, and financial management of clinical trials preferred.
    • Proficiency in writing SOPs, technical and programmatic reports.
    • Proficiency in the use of common software applications, including databases (REDCap, etc.), regulatory applications (eIRB, etc.), clinical computer systems (Epic, etc.), spreadsheets, and word processing.

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