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We are seeking a **_Sr. Research Program Coordinator II_** who will oversee the administrative and technical implementation of a complex* and/or multiple research projects. As part of the research team, collaborates with faculty to develop project plan(s), develop SOPs, and oversee all research-related activities for one or more complex projects. (*Complex to include, e.g. external partners, policy advocacy, significant community interventions.)

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 finance team to develop study budget(s) and ensure that all study costs are included in 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 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.

Technical Skills & Expected Level of Proficiency

+ Analytical Skills - Intermediate

+ Data Management and Analysis - Intermediate

+ Literature Reviews - Intermediate

+ Oral and Written Communication - Intermediate

+ Project Coordination - Intermediate

+ Regulatory Compliance - Intermediate

+ Research Data Quality Assurance - Intermediate

+ Research Design - Intermediate

+ Resource Management - Intermediate

+ Scientific Writing - Intermediate

Minimum Qualifications

+ Bachelor's Degree in related field.

+ Five years related experience in clinical research in an academic, government, or pharmaceutical industry environment.

+ 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

Job Posting Title (Working Title): Sr. Research Program Coordinator II (Plastic & Reconstructive Surgery)

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: M-F/37.5

FLSA Status: Exempt

Department name: SOM PRS Research

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.