MTA​/DUA Study Start-up Program Manager; Office of Clinical Trials

Specific Duties and Responsibilities

• Manage the day-to-day operations and staffing of the unit to streamline commercial MTA/DUA start-ups and maximize efficiencies while ensuring adherence to best practices, regulations/guidelines, and Standard Operating Procedures for human subjects protections and protocol integrity.
• Provide direction and coordination for Commercial MTA/DUA Program.
• Manage the end-to-end start-up process within the unit, from concept through activation.
• Supervise team of Commercial MTA/DUA regulatory specialists with activities including onboarding new clinical research operations personnel, performance evaluations, corrective actions, performance improvement plans, and career development.
• Facilitate effective teamwork among all involved personnel, e.g., regulatory specialists, research study teams, central research administrative personnel, etc.
• Partner and collaborate with the OCT Accelerated Study Start-up Program which is focused on commercial clinical trials.
• Provide support, guidance, and training to study teams to facilitate start-up of Commercial MTA/DUA including coordination and initiation of contract activities, initial applications to the IRB and other regulatory agencies, etc.
• Develop and implement systems for monitoring, reporting, and quality assurance activities.
• Communicate with and track activities led by internal and/or external research team members and collaborators.
• Monitor, track, and report critical study start-up milestones, e.g., IRB activities, processing and finalization of contracts, etc.; proactively manage and remove barriers to Commercial MTA/DUA project start-up.
• Liaison between study teams and central research administrative teams.
• Anticipate and mitigate risks to Commercial MTA/DUA project start-up.
• Develop and refine standard operating procedures for Commercial MTA/DUA project start-up activities.
• Collaborate with the Office of Research Administration in the coordination and initiation of contracts for new Commercial MTA/DUA projects.
• Contribute to meetings with program stakeholders and provide status updates and recommend changes to operations based on results and goals.
• Meet with institute- and department-based Research Council Chairs to address needs and concerns regarding new Commercial MTA/DUA project start-up, and communicate these needs, concerns, and action plans to the Director of OCT as appropriate.
• Represent the Commercial MTA/DUA Program on institute- and department-based Research Councils and other committees, task forces, and working groups as assigned or requested.

• Bachelor's Degree in a related field.
• Five years of related experience in clinical research in an academic, government, or pharmaceutical industry environment.
• Demonstrated knowledge and skills in accordance with Good Clinical Practice (GCP) guidelines, HIPAA, FDA regulations, and other federally mandated guidelines.
• Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

• Master's Degree in related field.
• Certification as a Clinical Research Professional.

Classified

Title:

Study Start-up Program Manager
Job Posting Title (Working Title): MTA/DUA Study Start-up Program Manager (Office of Clinical Trials)
Role/Level/Range: ACRP/04/MD
Starting Salary Range: $55,800 - $97,600 Annually ($75,000 targeted; Commensurate w/exp.)
Employee group:
Full Time

Schedule:

M-F 8:30 am - 5 pm
FLSA Status:
Exempt

Location:

Hybrid/School of Medicine Campus
Department name: SOM Admin Res Clinical Research Contract
Personnel area:
School of Medicine