Sr. Research Program Coordinator II (Plastic & Reconstructive Surgery)

Johns Hopkins University•Baltimore, MD

31d•Onsite

About The Position

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.)

Requirements

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.
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

Nice To Haves

Master's Degree in a related field.

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.