We are seeking a research project manager to manage a portfolio of investigator-initiated research projects. Projects include some multi-center clinical trials, retrospective studies and observational studies. Project managers provide oversight and management of the project team in coordination with study principal investigators and the Director in order to move the project forward efficiently and according to good clinical practice (GCP) guidelines. The position requires an individual who can manage multiple projects, prioritize competing deadlines, and who is energized by working in a dynamic research environment. The position is currently hybrid with some in office work, and some home-based. The position is full time (40 hours/week, M-F 8A-4:30P, benefits-eligible).
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
Communicate with principal investigators, the Director, and the department team while maintaining positive and cooperative relationships in day-to-day interactions
Maintain research project timelines and manage timely execution of deliverables by the research team
Coordinate and attend research investigator and coordinator meetings and teleconferences, including preparing agendas and taking minutes
Create and update research study manual of operations and standard data collection procedures for all participating clinical research sites
Participate in the development of research study protocols, and create study-specific informed consent document templates
Assist with design of electronic case report forms (CRFs), research database validation and variables for data entry, as well as implementing best practices for data capture
Maintain study master files, and manage the research study progress in relation to project timelines
Monitor studies for compliance with GCP and ICH guidelines, including completion of regulatory documents and proper completion of case report forms
Prepare and maintain all IRB submissions and continuing reviews
Education: Academic knowledge in a health science discipline that is generally associated with a Bachelor’s Degree. Master's degree, such as an MPH, preferred.
Experience: At least 3 years’ experience in clinical research, preferably as a project manager required. Proficient in electronic data capture systems, i.e. REDCap desired. Familiarity with the management of datasets, best practices for data security and management and with creation/maintenance of data dictionaries/code books desired. Familiarity with the content and processing of large sampled datasets from the Agency for Healthcare Research and Quality (AHRQ), including the National Inpatient Sample (NIS), National Readmission Database (NRD), etc. preferred. Understanding of statistical concepts which will be used for data management purposes preferred. Experiences in health services research preferred.
Certification/Licensure: Certification as a clinical research associate or the equivalent is desirable.
Trinity Health Ann Arbor is a 537 –bed teaching hospital located on 340 acre campus. Recognized by IBM Watson as a Top 100 Hospital and #1 Teaching Hospital, Trinity Health Ann Arbor has been a leading health care provider for more than 100 years. As part of Trinity Health we have received numerous local and national awards in recognition of our leadership, quality outcomes, and clinical excellence. Our personalized care is designed to heal each patient’s body, mind and spirit, as we provide hope, compassion, and the most advanced medical care in the communities we serve.