Research Program Coordinator, Full-time, Days - job 1 of 2

At Northwestern Medicine, every patient interaction makes a difference in cultivating a positive workplace. This patient-first approach is what sets us apart as a leader in the healthcare industry. As an integral part of our team, you'll have the opportunity to join our quest for better healthcare, no matter where you work within the Northwestern Medicine system. At Northwestern Medicine, we pride ourselves on providing competitive benefits: from tuition reimbursement and loan forgiveness to 401(k) matching and lifecycle benefits, we take care of our employees. Ready to join our quest for better?

The Research Program Coordinator reflects the mission, vision, and values of Northwestern Memorial, adheres to the organization’s Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines, and all other regulatory and accreditation standards.

The Research Program Coordinator: Conducts compliance and resource reviews of all Institutional Board (IRB) applications using NMH as a performance site; Coordinates and oversees the activities for the NMH Access Program for non-employee researchers;  Monitors and assures [in collaboration with OOR compliance and financial staff] that clinical research at NMHC is in compliance with all aspects of federal, state and local laws and regulations, and NMH policies; Ensures resolution of process or compliance deficiencies, and performs education and training of researchers as needed.

Responsibilities:

• Conducts pre-review of Institutional Board (IRB) applications to ensure compliance with hospital policies, and applicable federal/state research laws; Presents high risk studies to Research Compliance Coordinator or Office of Research Manager for determination; Endorses IRB applications for SVP when all requirements are met.
• Coordinates and oversees the NMH Access Program for non-employee researchers:
  • Independently conducts daily program activities and data management
  • Initiates and implements intra- and inter- department Process Improvement activities
  • Investigates issues hindering compliance and works with researchers and departments to educate/train research personnel and modify behavior.
  • Facilitates invoices (including Corporate Health and Background Checks)
  • Audits itemized payable and receivables activity of GL accounts for the NMH Access Program.
• Facilitates [with NU, NMH OGC, Materials Management and Sr. Administration] placement/lease agreement execution for non-NMH owned research equipment.
• Provides consultation to clinical researchers to complete various NMH ancillary processes prior to research subject enrollment.
• Serves as knowledgeable compliance resource to research campus including Northwestern University Faculty, NMH/NMPG Physicians and NU/NMH support staff.
• Supports and assists Office of Research Manager in identifying and assessing areas of research compliance risk for NMHC.
• Performs scheduled and ad-hoc educational sessions/presentations to clinical researchers.
• Assists with collection, analysis and reporting [to NMH Sr. Administration] of quarterly Office of Research process and outcome metrics.
• Functions as an alternate member on the Northwestern University Institutional Review Board.
• Assists in the development and/or revision of written policies, procedures and guidelines.
• Develops and maintains information related to position function on department web page.
• Performs Database maintenance.
• Monitors and tracks status reports of all current activity.
• Promotes professional development through increased responsibility, individual accountability, and continuing education

Additional Functions    

• Performs additional duties as required by Office of Research Manager and upon ad-hoc request by Director of Medical Affairs
• Assists with collection, analysis and reporting [to NMH Sr. Administration] of quarterly Office of Research program performance metrics.
• Maintains consistent high level of service

Required:

• Bachelor’s Degree in a relevant/supporting field OR equivalent demonstrated experience in program coordination with a minimum of 5 years in a clinical research environment at an academic medical center
• Some demonstrated knowledge of Institutional Review Board process, as well as Medicare Clinical Trial Policy regulations and Medicare Qualifying Clinical Trial guidelines
• Proficiency in data analysis and demonstrated database management experience
• Demonstrated consistency and reliability in level of output with focus on accuracy and thoroughness
• Meticulous organizational skills
• Excellent written and verbal communication abilities.

Preferred:

• At least 5 years demonstrated experience in a clinical research environment at a large academic medical center
• Healthcare experience

Northwestern Medicine is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation or any other protected status.

Benefits

We offer a wide range of benefits that provide employees with tools and resources to improve their physical, emotional, and financial well-being while providing protection for unexpected life events. Please visit our Benefits section to learn more.