John Hopkins University

Compensation

Full Description

Description: • Manage the recruitment, education, training and supervision of the regulatory and support personnel within the program. • Manage the end-to-end start-up process for commercially sponsored clinical studies, from receipt of a regulatory packet through protocol training and activation. • Manage the day-to-day operations to streamline study start-up and maximize efficiencies while ensuring adherence to best practices, regulations, guidelines, and Standard Operating Procedures for human subject's protections and protocol integrity. • Ensure the timely completion of the regulatory packet and proactively manage and remove barriers to study site activation. • Facilitate effective teamwork and communication among all internal stakeholders, e.g. program staff, research study teams, OCT teams, JHM IRB, SOM and JHU central resources. • Assess feasibility and operational needs of new studies and provide support, guidance, and training to study teams to facilitate each step in the start-up process. • 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, drafting of a complete budget, etc. • Serve as liaison between study teams and central research administrative teams and collaborate with the Office of Research Administration in the coordination and initiation of contracts and budgets for new studies. • Develop and refine standard operating procedures for study start-up activities and contribute to meetings with program stakeholders, providing status updates and recommending operational changes as appropriate. • Meet with institute- and department-based research councils, PIs, and research staff to address needs and concerns regarding study start-up and represent the Accelerated Study Start-up Program at committees, task forces, and working groups as assigned or requested. Requirements: • Bachelor's Degree in a related field. • Five years of related experience in clinical research in an academic, government, or pharmaceutical industry environment. • Experience with implementation of study start-up activities in interventional clinical trials. • Supervisory or lead experience. • Master's Degree in a related field (Preferred). • Certification as a Clinical Research Professional (Preferred). • Additional education may substitute for required experience, and additional related experience may substitute for required education per the JHU equivalency formula. • Successful candidate(s) will be subject to a pre-employment background check. • SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. • Pre-employment physical for positions in clinical areas may require documentation of immune status against Rubella, Rubeola, Mumps, Varicella, Hepatitis B and documentation of having received the Tdap vaccination. Benefits: • Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/. • Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.