Sr. Research Program Coordinator II (Plastic & Reconstructive Surgery)
Johns Hopkins University
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
Location: School of Medicine Campus
Department name: SOM PRS Research
Personnel area: School of Medicine