Sr. Clinical Research Coordinator II (Infectious Disease)

The Johns Hopkins University; Baltimore (MD); Hybrid; USD 49,000 - 86,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

The Johns Hopkins University in Baltimore's School of Medicine hosts the Division of Infectious Disease, seeking a Sr. Clinical Research Coordinator II to support RCCS, IN-STEP, SENTINEL and related studies.

You will oversee regulatory tasks, consent forms, SOP development, and data management across multiple sites. Responsibilities include budgeting with finance, IRB submissions, study coordination, and training staff.

Qualifications

• Bachelor's Degree in a related field.
• Five years of related experience.
• Additional education may substitute for required experience.

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 sponsors to determine feasible group commitments and resources.
• Develop study budgets with the finance team and ensure costs are included.
• Maintain regulatory files and approvals across Johns Hopkins and collaborating sites.
• Coordinate day-to-day administrative and operational activities for RCCS, IN-STEP, SENTINEL and related studies.

Skills

Regulatory coordination

Data management

Budgeting

Education

Bachelor's Degree in related field

Master's Degree (preferred)

Job description

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 8:30am - 5pm

FLSA Status: Exempt

Location: Hybrid/School of Medicine Campus

Department name: SOM DOM Infectious Disease

Personnel area: School of Medicine