PS Regulatory Coordinator Job Campus Illinois USA,Research/Development

Location: Campus

Priority Review Date (Note - Posting may close at any time)

Job Summary

The Huntsman Cancer Institute Clinical Trials Office (CTO) is hiring a coordinator to assist the Activation Project Administrator in various activation activities for oncology clinical trials conducted at Huntsman Cancer Institute. Responsible for assisting in evaluating new clinical trial opportunities for HCI with faculty principal investigators and clinical trial research managers and administrators. This will include assisting in facilitating and building strategic relationships with research partners;

facilitation, tracking and execution of confidentiality agreements, completing feasibility questionnaires, conducting pre-study site visits, and tracking of the opportunities and outcomes. Serve as liaison with sponsors and vendors; assist with deliverables to clinical trial research multi‑disciplinary teams; oversee project agreements; and nurture internal & external partnerships.

Responsibilities

Coordinates activation workflows to ensure appropriate timelines are met.

Execution of confidentiality agreement for all clinical trial opportunities.

Assists in maintaining trial activation resources, brochures and start‑up materials for activation process.

Completes feasibility questionnaires for clinical trials presented to the Clinical Trials Office.

Liaison with internal or external clients, sponsors, or partners for assigned studies, projects, or programs. Lead contact for all project matters; understand and manage contractual and organizational client expectations; nurture client relationship and needs. Provide to the sponsor regular reports on project status, certain metrics, and issues.

Manage project deliverables. Track progress by keeping close metrics, including but not limited to time and quality. Be accountable for follow‑up on action items. Work with the Project Administrator and Manager in identifying, resolving, or escalating issues.

Represent the Clinical Trials Office in HCI Clinical Trial Research Group meetings.

Complete intake Clinical Trial Research Group new study review and prioritization forms.

Submit trial packages to the Feasibility Administrative Review committee and follow‑up on action items to achieve approval.

Liaise with the Office of Sponsored Projects and CTO Finance Pre‑Award team to ensure appropriate and timely execution of CDAs, CTAs and study budgets. Assist in scheduling calls and supporting negotiations in these areas.

In cooperation with research managers and administrators, organize and actively participate in sponsor site visits.

Serve as an internal liaison to bridge trials from activation to start‑up.

Act as a liaison between study sponsors, HCI investigators and the Clinical Trials Office by evaluating problems and providing solutions.

Understand and act within the framework of regulatory guidelines provided by federal, state, and local regulatory agencies and ethical guidelines pertaining to the conduct of clinical research.

Promote a positive work environment that is maintained through open and effective communication.

Serve as first point of contact for potential outside CROs and sponsors. Be the face of the HCI CTO.

Establish and foster strong relationships and interactions with HCI investigators, study sponsors and the Clinical trials office personnel.

Ensure high quality of data and metrics to study sponsors and research teams.

Assist in process and efficiency improvements in the trial activation area.

Must be able to work independently and have strong communication and human relations skills.

Minimum Qualifications

Bachelor’s degree in a research or related area plus two years clinical trials/research experience or equivalency (one year of education can be substituted for two years of related work experience) required; demonstrated human relations and effective communication skills also required.

One year of regulatory experience, an understanding of medical terminology and technical writing experience preferred.

This position is patient‑sensitive and must fulfill all associated requirements. We protect our patients, coworkers and community by requiring all patient‑sensitive employees to be…