RESEARCH TRIALS OFFICE MANAGER

RESEARCH TRIALS OFFICE MANAGER

• Facility Sinai Health System
• Department SHS SHS INSTITUTL REV BD
• Job Category Business Professional
• Shift Days
• Schedule Full Time
• Req # 27690

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About Us:

At Sinai Health System d/b/a Sinai Chicago, we take health care personally. Excellence in health care is about more than just medicine, technology, tests, and treatments, it is about really caring for people with dignity and respect. That is what we do. We are dedicated to providing the best care to meet the needs of people, for our community, for our patients and for you.

Organizational Context

Expansion of clinical trials by Sinai Chicago is a new and strategically significant initiative launching in July 2026, with a planned portfolio of 3 active trials by the end of FY27, growing to 10 trials in FY28 and 20 trials in FY29. The program will operate in collaboration with pharmaceutical and medical device sponsors through CROs or individual PI's, government research agencies, Sinai Urban Health Institute, and as opportune, other academic partners. We intend to make clinical research accessible to the marginalized, predominantly Black and Latino communities that constitute the majority of Sinai's patient population.

The Research Trials Office (RTO) Manager will be the first managerial hire in the clinical trials expansion, and the RTO Manager will actively participate in the design and build-out of the program's operational infrastructure during the pre- and early-launch period, maturing, and scaling phases in FY27 and FY28.

Position Purpose:

The Research Trials Office Manager (RTO Manager) stands at the operational hub of Sinai Chicago's trials expansion, providing the administrative, financial, regulatory, and organizational infrastructure that enables investigators and clinical research staff to focus on the scientific and clinical work of the program. This is a proactive, systems-oriented leadership role responsible for the operational integrity of a growing portfolio of clinical trials across service lines. The RTO Manager will balance and manage the demands of operational excellence in clinical research, participant protection, scientific rigor, and institutional accountability.

This position reports to the Director, OGGA.

Key Job Activities:

Program Operations and Trial Life cycle Management:

Serves as the central operational coordinator for all active and pipeline clinical trials, maintaining comprehensive visibility into protocol status, milestones, and operational needs across all service lines. Oversees the trial activation process (either by direct conduct or more likely in conjunction with a Contract Research Organizations (CRO's Clinical Research Coordinator(CRC) administering the effort) from feasibility assessment through site initiation visit; coordinates all pre-activation requirements: protocol review, budget and contract negotiation (with the director and other's participation); IRB submission and

Commented [HM1]: Spell these out at first use.

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Approval (whether through a central IRB or at Sinai); and any staff training, delegation logs, pharmacy setup, and CTMS protocol building or its review.

Oversees CRO's close-out efforts or conducts/oversees the study closeout process for each trial, ensuring all protocol-required procedures are completed, data queries resolved, regulatory documents archived by FDA and sponsor retention requirements, and final invoices are submitted.

Coordinates scheduling and logistics with CRO's and/or PI's for sponsor monitoring visits, co-monitoring visits, and FDA or sponsor audits, including preparation of regulatory binders, source documentation, and corrective action and preventive action (CAPA) response plans when monitoring findings require remediation.

Maintains a Sinai CTMS when available as the system of record for all study operational data; serves as CTMS super-user and vendor liaison, and manages system configuration changes, user access, and staff training on the platform. In conjunction with the Director of OGGA and the Chair of the IRB, develops, maintains, and annually reviews standard operating procedures (SOPs) for all core research operations functions, including enrollment, informed consent, adverse event reporting, protocol deviation management, investigational product accountability, specimen processing, and monitoring visit preparation.

Regulatory Compliance and Quality Management:

Serves as the program's primary regulatory compliance resource for non-clinical regulatory questions, working in close collaboration with CRO regulatory and the MSH-IRB IRB coordinator on all matters requiring regulatory authority or IRB expertise.

Maintains the program's regulatory infrastructure, including OHRP Federal Wide Assurance registration,

Knowledge and Skills:

Knowledge of FDA regulations governing clinical trials (21 CFR Parts 11, 50, 54, 56, 312, 314, 812), ICH-GCP guidelines (E6 R2), and OMB Uniform Guidance (2 CFR 200)

Knowledge of clinical trial budget development, sponsor invoice management, and research billing

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Strong project management and organizational skills; ability to manage or oversee concurrent trials across diverse therapeutic areas without loss of operational oversight

Knowledge of electronic regulatory binder systems and EDC platforms

Knowledge and skills working with Epic or Meditech preferred; familiarity with Epic Research Module a plus

Exceptional interpersonal and communication skills; ability to work effectively with investigators, clinical staff, sponsors, regulators, and institutional leadership

Commitment to health equity and experience working in safety-net or underserved community health settings preferred.

Experience in EPIC and MEDITECH software systems preferred.

Certifications/Licenses:

Certified Clinical Research Professional (CCRP) is desirable. Formal, advanced clinical training and appropriate trial experience can be initially substituted

ACRP or SOCRA certification preferred or desired within 18 months of hire

GCP certification (ICH-GCP E6 R2) or desired within 18 months of hire

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