Sr. Research Program Coordinator II

We are seeking a Sr. Research Program Coordinator II to work within the Division of Clinical Pharmacology Drug Development Unit and

support clinical studies sponsored by pharmaceutical companies, government agencies, and Johns Hopkins investigators. Subject populations involved in the studies include healthy adults and various populations with disease.

Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. The Sr. Clinical Research Coordinator II oversees the administrative and scientific implementation of clinical protocol for a complex* and/or multiple research studies. As part of the study team, collaborates with faculty to develop protocols, develop SOPs, and oversee study-related activities for one or more complex studies. (*Complex to include studies with investigative drugs and devices, or multi-center studies.)

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 clinical trials 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 the 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.

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 related field

Classified Title: Sr. Research Project Coordinator II

Job Posting Title (Working Title): Sr. Research Program Coordinator II (DOM Clinical Pharmacology)

Role/Level/Range: ACRP/04/MC

Starting Salary Range: $48,000 - $84,100 Annually ($66,000 targeted; Commensurate w/exp.)

Employee group: Full Time

Schedule: Mon-Friday 8:30-5pm

FLSA Status: Exempt

Location: School of Medicine Campus

Department name: SOM DOM Clinical Pharmacology

Personnel area: School of Medicine

Equal 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.