Trinity Health Academic Research Project Manager in Ann Arbor, Michigan

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.

Responsibilities Include:*

  • 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;
  • 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;
  • Regular reporting of project milestones and deliverables to Director.

Desired Qualifications*

  • Master's degree strongly degree preferred, especially in the disciplines of epidemiology, biostatistics, or public health;
  • 1-2 years of experience in the health services research area;
  • Familiarity with the management of datasets, best practices for data security and management and with creation/maintenance of data dictionaries/code books;
  • 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.;
  • Understanding of statistical concepts which will be used for data management purposes;
  • Certification as a clinical research associate or the equivalent is desirable;
  • Proficient in electronic data capture systems, i.e. REDCap;

Apply

Job Number: 00093312

Location: Ann Arbor, MI

Organization Name: Saint Joseph Mercy Health System

Facility: SJSEMI - SJMHS Reichert Health Ctr

Employment Type: Full time

Shift: Day Shift

Hours: 40