Clinical Research Supervisor (Urology)

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 mangers 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.