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Research Regulatory Coordinator

NorthShore University HealthSystem
paid time off, tuition reimbursement
United States, Illinois, Evanston
2650 Ridge Avenue (Show on map)
Feb 21, 2025

Position Highlights:

  • Position: Research Regulatory Coordinator
  • Hourly Pay Range: $26.61-$39.62/hour. The hourly pay rate offered is determined by a candidate's expertise and years of experience, among other factors
  • Location: Evanston, IL
  • Full Time/Part Time: Full Time
  • Hours: Monday-Friday, 40 hours

Position Summary:

The Regulatory Coordinator for the Clinical Trials Center is accountable for the management of regulatory documentation for specific clinical research protocols and disease related databases. The position maintains a collaborative relationship with Principal Investigators, Co-investigators, inter-departmental staff and research administration staff, in addition to representatives of outside sponsoring companies and/or agencies. Assists the Administrative Director of the Clinical Trials Center with clinical trials management, program planning, coordination of clinical research studies, IRB processing and compliance with federal, state, local, and institutional research regulations and maintenance of related databases. The coordinator will report directly to the Administrative Director of the Clinical Trials Center and to the Assistant Vice President for Research Administration.

What you will do:

  • Compliance with Endeavor Health Research Institute Guidelines
  • Collaborate with investigator and sponsor/CRO to prepare IRB submissions, consent forms and revisions
  • Submission of research applications, revisions, modifications, amendments, and periodic progress reports
  • Protocol initiation with Principal Investigators, Sponsors, and Research Coordinators
  • Provides the study sponsor, IRB and others as needed with documentation of credentials
  • Obtains written IRB approval prior to initiating the study or instituting any changes to the protocol. Communicates approval to Principal Investigator, Sponsor/CRO and others as needed.
  • Assures the Proper Storage of Investigational Articles
  • Prepares regulatory documents for sponsor/audit review
  • Protects the rights and welfare of research subjects
  • Assists investigators with information and materials required to complete grant and contract applications for clinical trials; maintains and submits timely data; updates and maintains clinical trial files and databases.

What you will need:

  • Education: Bachelor's degree preferably in science biology, psychology, sociology public health, or related discipline required
  • Experience: Minimum of 2 years of progressive experience in clinical research administration. Knowledge of federal regulations and rules for human subject protection.
  • Skills: Strong Planning, organizational and problem-solving skills, effective communication (both written and verbal) to interact in a professional and sensitive manner with medical personnel,

Benefits (For full time or part time positions):

  • Career Pathways to Promote Professional Growth and Development
  • Various Medical, Dental, Pet and Vision options
  • Tuition Reimbursement
  • Free Parking
  • Wellness Program Savings Plan
  • Health Savings Account Options
  • Retirement Options with Company Match
  • Paid Time Off and Holiday Pay
  • Community Involvement Opportunities

Endeavor Health is a fully integrated healthcare delivery system committed to providing access to quality, vibrant, community-connected care, serving an area of more than 4.2 million residents across six northeast Illinois counties. Our more than 25,000 team members and more than 6,000 physicians aim to deliver transformative patient experiences and expert care close to home across more than 300 ambulatory locations and eight acute care hospitals - Edward (Naperville), Elmhurst, Evanston, Glenbrook (Glenview), Highland Park, Northwest Community (Arlington Heights) Skokie and Swedish (Chicago) - all recognized as Magnet hospitals for nursing excellence. For more information, visit www.endeavorhealth.org.

When you work for Endeavor Health, you will be part of an organization that encourages its employees to achieve career goals and maximize their professional potential.

Please explore our website (www.endeavorhealth.org) to better understand how Endeavor Health delivers on its mission to "help everyone in our communities be their best".

Endeavor Health is committed to working with and providing reasonable accommodation to individuals with disabilities. Please refer to the main career page for more information.

Diversity, equity and inclusion is at the core of who we are; being there for our patients and each other with compassion, respect and empathy. We believe that our strength resides in our differences and in connecting our best to provide community-connected healthcare for all.

EOE: Race/Color/Sex/Sexual Orientation/ Gender Identity/Religion/National Origin/Disability/Vets, VEVRRA Federal Contractor.

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