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 MedicineEqual Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.