Clinical Research Supervisor (Urology)

Clinical Research Supervisor

We are seeking a Clinical Research Supervisor in the department of Urology. Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. The Clinical Research Supervisor administratively coordinates clinical protocol implementation for a single study or multiple studies. A primary responsibility will be supervision of a minimum of two full-time research team members carrying out protocol-related operational tasks.

The Clinical Research Supervisor is responsible for overseeing the conduct of multiple clinical research studies, supervising research staff, and ensuring regulatory compliance and data quality. The role involves direct supervision of Research Assistants, daily communication with staff and investigators, and proactive management of workplace issues to maintain a professional, productive, and collaborative team environment.

Specific Duties & Responsibilities

• Coordinate all activities of a clinical research study to ensure adherence to protocol and validity of findings.
• Facilitate administrative hiring processes and participate in staff interviews and hiring decisions.
• Delegate and oversee performance of study tasks.
• Set performance goals, coach staff, and conduct performance evaluations.
• Participate in clinical study start-up meeting.
• Assist research nurses, principal investigators, and other study personnel in executing protocol-related activities.
• Understand and explain the study background and rationale for the research to potential and current participants and/or assigned research staff.
• Contribute to the recruitment strategy for participants for assigned study.
• Implement a variety of techniques for recruitment as needed, e.g. print and web-based advertisements, contact referring physicians, participate in community events, etc. and involve and oversee staff.
• Independently conduct the consenting process or ensure consent is obtained on appropriate participants by trained staff.
• Contact, or oversee contact of, participants to schedule for required activities and with special instructions prior to upcoming tests/exams.
• Assist with, or oversee the setup of, the data collection system and entry and organization of data.
• Assist in coordinating study meetings.
• Participate in study meetings and provide updates on protocol implementation status and make recommendations on operational issues.
• Assist with the preparation of submissions to the Institutional Review Board (IRB).
• Liaison with the IRB on administrative matters and facilitate communications with PI.
• Conduct literature searches to provide background information.
• Obtain and maintain excellent operating knowledge of assigned clinical protocols, clinical equipment, and clinical computer systems.
• Oversee budget expenditures for study operations.
• Other duties as assigned.

In addition to the duties described above

• Supervise the day-to-day activities of the OB Gyn and Qualitative Database team inclusive of training, and manage scheduling, workload balancing, and task delegation among staff.
• Oversee data integrity, source verification, and query resolution while coordinating with data managers and statisticians to ensure clean, analyzable data sets.
• Prepare and submit Initial IRB submissions, amendments, continuing reviews, and reportable events to the IRB while serving liaison with the JHU IRB, ClinicalTrials.gov, and external sponsors.
• Foster a positive work culture through regular one-on-one check-ins, team meetings, and constructive feedback.

Minimum Qualifications

• Bachelor's Degree in a related field.
• Two years of related experience.
• Additional education may substitute for required experience and additional related experience may substitute for required education permitted by the JHU equivalency formula. Beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

• Lead or supervisory experience.
• Five years of experience in urologic research.
• Prior experience in urologic oncology clinical trials research.

Technical Qualifications & Specialized Certifications

• Participation and timely completion of JHU supervisory classes.

Technical Skills & Expected Level of Proficiency

• Budget Management - Advanced
• Clinical Research Participant Recruitment - Advanced
• Clinical Research Knowledge - Advanced
• Data Management and Analysis - Advanced
• Good Clinical Practices - Advanced
• Interpersonal Skills - Advanced
• Oral and Written Communications - Advanced
• Project Management - Advanced
• Regulatory Compliance - Advanced
• Stakeholder Engagement - Advanced

The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.

Classified Title: Clinical Research Supervisor Job Posting Title (Working Title): Clinical Research Supervisor (Urology) Role/Level/Range: ACRO40/E/03/CE Starting Salary Range: $19.75 - $35.35 HRLY ($25.00-$27.50/hour targeted; Commensurate w/exp.) Employee group: Full Time Schedule: M-F, 8:00am - 4:30pm FLSA Status: Exempt Location: School of Medicine Campus Department name: SOM Uro Urology Research Personnel area: School of Medicine