CLINICAL RESEARCH REGULATORY COORDINATOR

LOCATION: RUTH ROTHSTIEN CORE CENTER

DEPARTMENT: CORE RESEARCH

SHIFT: 9:00 AM- 5:00 PM

This position is exempt from Career Service under the CCH Personnel Rules.

JOB SUMMARY: NON-UNION

The Clinical Research Regulatory Coordinator is responsible for supporting clinical research regulatory compliance operations at the institution. Manages and executes the regulatory compliance activities of a clinical research study being conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations, guidelines and institutional policies and procedures. Actively collaborates with internal and external teams.

TYPICAL DUTIES:

• Analyzes regulatory requirements, identifies any potential conflicts, and ensures smooth implementation of trials
• Maintains compliance and integrity of clinical research regulatory files in paper and electronic formats
• Prepares, manages, completes, and submits protocol Institutional Review Boards (IRB) submissions throughout the clinical research lifecycle from study startup through study closeout, including amendments, safety reports, renewals, unanticipated problems, deviations, etc.
• Facilitates IRB approval for subject recruitment materials as required by the IRB of record, state, and federal research regulations
• Ensures that research patient informed consent materials adhere to institutional, sponsor, and IRB policies and guidelines. Revises, negotiates, and finalizes informed consent language with Sponsors to ensure adherence to protocol, IRB requirements, and institutional policies
• Collaborates with the Principal Investigator (PI) and external Sponsor teams to complete required regulatory documents including, but not limited to conflict-of-interest forms, delegation of authority logs, legal agreements, investigational pharmacy forms, serious adverse event (SAE) forms, etc.
• Provides timely and accurate updates to the research team throughout the lifecycle of the trial, including notification of clinical trial activation, enrollment closures, protocol amendments, and final study closures
• Ensures files are continuously updated, prepared and audit ready. Participates in internal and external audits. Addresses questions and compliance-related findings in a timely manner
• Ensures accurate completion of internal department tracking tools with protocol specific information
• Evaluates processes for recurrent problems and develops and implements quality control systems or processes to reduce errors
• Assists in the development and implementation of clinical research and regulatory Standard Operating Procedures (SOPs)
• Remains current regarding regulations, regulatory guidance, and/or local institutional policies

MINIMUM QUALIFICATIONS:

• Bachelor 's degree from an accredited college or university is required. (Must provide official transcripts at time of interview)
• A minimum of three (3) years of clinical research experience is required.
• Experience in clinical research regulatory setting is required.
• Experience in Institutional Review Board (IRB) and Federal Regulations governing human subject research is required.
• Experience with Good Clinical Practice and International Conference on Harmonization (GCP/ICH) guidelines, Food and Drug Administration (FDA) guidance, regulations is required.
• Proficiency using Microsoft Office is required.

PREFERRED QUALIFICATIONS:

• Regulatory Affairs Certification (RAC), Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required.

KNOWLEDGE, SKILLS, ABILITIES AND OTHER CHARACTERISTICS:

• Knowledge of medical terminology
• Knowledge of Good Clinical Practice (GCP) and human research protections
• Knowledge of clinical trial regulatory tasks and ensures operations are managed in compliance with Knowledge and experience with clinical trials
• Knowledge of regulations governing the use of human subjects in clinical trials, outcomes research, and other clinical research areas* Knowledge and of the IRB submission and approval process
• Excellent verbal and written communication skills necessary to communicate with all levels of staff and a patient population composed of diverse cultures and age groups
• Knowledge of FDA regulations and institutional policies and procedures
• Ability to prioritize, plan, and organize projects and tasks
• Ability to multi-task and meet deadlines in a fast paced and stressful environment
• Strong critical thinking and reasoning skills
• Strong customer service skills
• Demonstrate attention to detail, accuracy, and precision

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)
• 100% Tuition Reimbursement for nursing-related programs

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 bust 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