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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