Sr. Clinical Research Coordinator II (Infectious Disease)

Responsibilities

• Collaborate with the Principal Investigator and study team to ensure operational feasibility of proposed protocol/study design.
• Develop standard operating procedures and data collection forms from protocol(s).
• Develop consent form(s) for studies based on protocol(s).
• Prepare materials for submission to the IRB and follow up on regulatory issues.
• Train and provide oversight of research data management and regulatory issues.
• Work with commercial and/or government agency sponsors to recommend and/or determine appropriate patient populations, resources, and cost considerations.
• Work with the finance team to develop study budget(s) and ensure all study costs are included.
• Ensure clinical research protocols have a completed Prospective Reimbursement Analysis (PRA) and that related processes/systems are followed.
• Maintain systems for tracking and reporting clinical research milestones for financial invoicing.
• Initiate and maintain activities, systems, and processes to increase referrals and accruals to clinical trials.
• Participate in development, testing, and evaluation of manuals, questionnaires, and coding structures for efficient data collection.
• Organize and quality‑control study data.
• Oversee data collection at a single site or across multiple sites of a multi‑centered clinical trial.
• Perform self‑audits and/or audit other sites.
• Participate in study meetings to present data, provide status updates, recommend protocol operational changes, and suggest ideas for sub‑studies.
• Extract data, review literature, and assist with preparation of manuscripts and presentations as appropriate.
• May oversee day‑to‑day activities and provide training for study staff.
• Coordinate day‑to‑day administrative and operational activities for RCCS, IN‑STEP, SENTINEL, and other CCGHE‑ID/RHSP‑related research studies.
• Maintain regulatory files and track approvals, expirations, and required submissions across Johns Hopkins, RHSP, and collaborating institutions.
• Serve as a central point of contact for investigators, RHSP staff, laboratories, and collaborators to support communication and follow‑up.
• Other duties as assigned.

Minimum Qualifications

• Bachelor’s Degree in a related field.
• Five years of related experience.
• 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.

Preferred Qualifications

• Master’s Degree in a related field.

Pay

Starting Salary Range: $49,200 – $86,200 annually (commensurate with experience).

Schedule

Monday to Friday, 8:30 am – 5:00 pm.

Classified Title: Sr. Clinical Research Coordinator II | Employee Group: Full Time | FLSA Status: Exempt | Location: Hybrid/School of Medicine Campus | Department: SOM DOM Infectious Disease (School of Medicine).