Job Description

The Program Coordinator, NCORP supports National Cancer Institute Community Oncology Research Program (NCORP) Clinical Trial Regulatory Research activities, under direction of the Program Administrator for NCORP. Conducts routine audits, prepares site regulatory documents, and provides updates on new protocols undergoing Institutional Review Board (IRB) review.



This is a grant-funded position, will expire on July 31st, 2026, with the potential to be renewed.

TYPICAL DUTIES

Collaborates with NCORP Administrator to coordinate Clinical Trial Regulatory Research matters, providing support and clinical trial updates to the NCORP team. Liaisons with CIRB, CCH IRB and the Director of Research and Regulatory Affairs to track receipt of ALL approval letters regarding annual renewal, amendments/addenda, and consent form changes and study updates. Assists with the agenda planning and conduct of NCORP Clinical Trials working group meeting, which includes scheduling bi-weekly meetings. Performs searches for all clinical trial updates, study closures, amendments, consent updates, new study activations. Monitors training or credentialing requirements to ensure staff remain in compliance as outlined in the protocol. Ensures collaboration agreement/feasibility with Pathology, Pharmacy and other collaborators. Collaborates with staff to manage the Delegation of Task Logs (DTLs). Provides updates and necessary follow-up on new protocols undergoing Institutional Review Board review. Completes all necessary administrative documentation for opening new protocols, including obtaining required signatures, obtaining Clinical IRB approval, and submitting required information through the IRB Manager website. Prepares site regulatory documents ensuring completeness and accuracy. Maintains electronic study binders according to protocol requirements and department policy. Completes informed consent documents with approved boilerplate language and updates. consent forms daily due to addendum updates, saves all updated consent forms in appropriate folders. Provides copies of patient informed consent forms and other research support information to physicians, and CRA's for clinical activities. Enters clinical trial information into NCORP clinical trial access database. Completes pre-audit projects, assists with document preparation for cooperative group audits, and submits requested pre-audit documents to the cooperative group site staff. Conducts quarterly internal audits ensuring accuracy of consent version, verifies a second CRA signed off on eligibility criteria, and ensures all study updates and amendments have been discussed and properly documented in the Clinical Trials Working Group meeting minutes. Communicates with sponsors on specific protocol data and requested information, as needed. Manages the main NCORP phone line. Follows procedures to protect and maintain the rights and confidentiality of all human study participants. Participates in meetings and staff development activities. Performs other duties as assigned to support NCORP regulatory requirements.

Grant Administration

Assists with organization of research related materials and data collection for grant applications for external funding Assists with grant reporting data search of all clinical trials and accrual data Responsible for all submission of check request reimbursements and invoice payment

MINIMUM QUALIFICATIONS:

High School Diploma or GED equivalent Four (4) years of Institutional Review Board (IRB) experience One (1) year of experience working with research bases, i.e., ECOG-ACRIN, NRG Experience in evaluating and documenting audit procedures Proficiency in using Microsoft Office tools, including Access, Excel

KNOWLEDGE, SKILLS, ABILITIES AND OTHER CHARACTERISTICS:

Knowledge of clinical trials components including informed consent; eligibility; adverse events. Thorough understanding of auditing processes and approval processes In-depth knowledge and understanding of complex audits that require interpreting regulations, guidelines, and compliance issues Excellent verbal, written communication, and interpersonal skills necessary to communicate with all levels of staff and a patient population composed of diverse cultures and age groups Demonstrate analytical and organizational, problem-solving, decision-making, critical thinking, and conflict management/resolution skills Ability to adhere to department policies and standards utilizing best practices Ability to meet deadlines Ability to think conceptually and work collaboratively

VETERAN PREFERENCE

PLEASE READ

When applying for employment with the Cook County Health & Hospitals System, preference is given to honorably discharged Veterans who have served in the Armed Forces of the United States for not less than 6 months of continuous service



To take advantage of this preference a Veteran

must

Meet the minimum qualifications for the position. Identify self as a Veteran on the employment application by answering yes to the question by answering yes to the question, "Are you a Military Veteran?" Attach a copy of their

DD 214, DD 215 or NGB 22

(Notice of Separation at time of application filing. Please note: If you have multiple DD214s, 215s, or NGB 22S, Please submit the one with the latest date. Coast Guard must submit a certified copy of the military separation from either the Department of Transportation (Before 9/11) or the Department of Homeland Security (After 9/11).

Discharge papers must list and Honorable Discharge Status. Discharge papers not listing an Honorable Discharge Status are not acceptable

OR

A copy of a

valid State ID Card or Driver's License

which identifies the holder of the ID as a Veteran, may also be attached to the application at time of filing.

If items are not attached, you will not be eligible for Veteran Preference

VETERANS MUST PROVIDE ORIGINAL APPLICABLE DISCHARGE PAPERS OR APPLICABLE STATE ID CARD OR DRIVER'S LICENSE AT TIME OF INTERVIEW.

BENEFITS PACKAGE

Medical, Dental, and Vision Coverage

Basic Term Life Insurance

Pension Plan

Deferred Compensation Program

Paid Holidays, Vacation, and Sick Time

You may also qualify for the Public Service Loan Forgiveness Program (PSLF)

For further information on our excellent benefits package, please click on the following link:

http://www.cookcountyrisk.com/

MUST MEET ALL REQUIRED QUALIFICATIONS AT TIME OF APPLICATION FILING.

Degrees awarded outside of the United States with the exception of those awarded in one of the United States' territories and Canada must be credentialed by an approved U. S. credential evaluation service belonging to the National Association of Credential Evaluation Services (NACES) or the Association of International Credential Evaluators (AICE). Original credentialing documents must be presented at time of interview.

Please note all offers of employment are contingent upon the following conditions: satisfactory professional & employment references, healthcare and criminal background checks, appropriate licensure/certifications and the successful completion of a physical and pre-employment drug screen.

CCHHS is strictly

prohibited

from

conditioning,

basing

or knowingly

prejudicing

or affecting

any

term

or

aspect

of

County

employment

or

hiring

upon

or

because

of

any political

reason

or

factor.

COOK COUNTY HEALTH & HOSPITALS SYSTEM IS AN EQUAL OPPORTUNITY EMPLOYER.