Sr. Clinical Research Coordinator II (Infectious Disease)

The Division of Infectious Disease is seeking a Sr. Clinical Research Coordinator II who will provide administrative, regulatory, and operational support for the portfolio that includes the Rakai Community Cohort Study (RCCS), IN-STEP clinical trial, the SENTINEL study, and multiple ancillary and investigator-initiated studies focused on HIV, sexually transmitted infections, non-communicable diseases, and related population health research.

Specific Duties & Responsibilities

• Collaborate with PI 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 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 what group can commit to considering patient population, available resources, and cost of providing services.
• Work with the finance team to develop study budget(s) and ensure that all study costs are included in the budget.
• Ensure clinical research protocol has a completed Prospective Reimbursement Analysis (PRA), and processes/systems are in place to ensure the PRA is followed when required.
• Ensure adequate system for tracking and reporting clinical research milestones for financial invoicing.
• Initiate and/or maintain activities, systems and processes to increase referrals and increase accruals to clinical trials.
• Participate in development, testing and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data.
• Organize and quality control study data.
• Oversee data collection at a single site or at 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 changes to protocol operations based on results and goals, 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.
• Other duties as assigned.
  
  

In addition to the duties listed above

• 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.
  
  

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.
  
  

Classified Title: Sr. Clinical Research Coordinator II

Role/Level/Range: ACRP/04/MC

Starting Salary Range: $49,200 - $86,200 Annually (Commensurate w/exp.)

Employee group: Full Time

Schedule: Monday to Friday 5:30am - 5pm

FLSA Status: Exempt

Location: Hybrid/School of Medicine Campus

Department name: SOM DOM Infectious Disease

Personnel area: School of Medicine