Regulatory Audit Coordinator

COG Research Foundation, LLC; Polska; Hybride; PLN 275 000 - 399 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid time off

Résumé du poste

COG Research Foundation, LLC is seeking a Regulatory Audit Coordinator to manage regulatory components of COG audits and ensure compliance with federal regulations and COG policies. The role includes reviewing IRB submissions and consent documents to align with the COG template and SOPs.

The position requires strong attention to detail, experience with oncology trials, and ability to interact with sites, reviewers, and regulators while traveling as needed.

Qualifications

• Experience reviewing IRB submissions and consent forms for compliance.
• Knowledge of FDA regulations and ICH-GCP guidelines.
• Ability to analyze protocols and regulatory documents for findings.

Responsabilités

• Conduct regulatory reviews for IRB submissions and ICC content.
• Translate findings into draft audit reports for sites and auditors.
• Manage regulatory audit summaries and track corrective actions.
• Coordinate with NCI CIRB and other regulators as needed.
• Review protocol deviations and early closure forms for compliance.

Connaissances

Regulatory audits

IRB submissions

FDA regulations

ICH guidelines

Regulatory reporting

Formation

Bachelor’s degree in biology or related field

Outils

Medidata Rave

Description du poste

COG Research Foundation, LLC (Research Foundation) is a California 501(c)(3) entity founded in 2024 to serve as a fiscal sponsor to support research programs by providing legal, fiduciary, and administrative oversight for the program. The Research Foundation serves as the fiscal sponsor for the Children’s Oncology Group (COG).

COG, a member of the National Cancer Institute (NCI) National Clinical Trials Network (NCTN), is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. COG unites over 13,500 experts in childhood cancer at more than 220 leading children’s hospitals, universities, and cancer centers across the United States, Canada, Australia, New Zealand, and Saudi Arabia to conduct more than 50 active clinical trials, with approximately 9,500 participants registered each year in the fight against childhood cancer.

Position Summary

All staff are employed through the Research Foundation. This role will be in service to COG.

The primary responsibility for the Regulatory Audit Coordinator is to conduct the regulatory component of COG audits for all COG institutions as defined in the NCI’s Clinical Trials Monitoring Branch (CTMB) guidelines. This requires diligent review of IRB submission and review of institutional informed consent documents to ensure compliance with the COG template and appropriate policies.

Additionally, the Regulatory Audit Coordinator is responsible for receipt and review of submitted regulatory documents for compliance with federal regulations and COG policies by reviewing regulatory document submissions for fully industry funded COG studies, as well as review of protocol deviation forms submitted in Medidata Rave and early closure forms from sites.

The COG Research Foundation, LLC is a 100% remote employer, though some travel may be required. Employee must reside within the United States.

Full salary range for this position: $70,296 to $101,911 per year. The typical hiring range for this position is from $70,296 (minimum) to $86,104 (midpoint), based on 100% FTE. The starting salary is determined based on the candidate’s knowledge, skills, experience, as well as budget availability.

Essential Duties and Responsibilities

COG Audit Program

• Conduct reviews of Institutional Review Board (IRB) submissions and Informed Consent Content (ICC) for the regulatory component of COG audits.
• Record audit findings on regulatory audit worksheets and translate findings into draft audit reports for distribution to sites and on-site auditors.
• Distribute finalized audit findings to the site and on-site auditors in accordance with applicable SOPs, ensuring compliance with established timelines.
• Identify and clarify any discrepancies, ambiguities or unsupported findings with the Senior Director of Quality Assurance & Audit prior to report finalization.
• Respond to complex questions from institutions or physician auditors regarding regulatory findings.
• Review and evaluate corrections from sites and update regulatory summaries to reflect accurate findings.
• Conduct second and for cause regulatory audits, as applicable.
• Develop and maintain regulatory audit summary and correction templates for use during regulatory audits.
• Prepare presentations, organize slides and present to site Clinical Research Associates (CRAs) at the Quality Assurance (QA) and Audit education sessions at COG Group Meetings and virtually.
• Participate in COG audit discussions with the NCI CIRB and other regulatory bodies.
• Respond to site questions regarding the regulatory component of the audit.

Protocol Deviations

• Oversee the intake and review of protocol deviation forms in accordance with protocol requirements and internal SOPs, downloading and routing forms for QA leadership review and entering queries in the as necessary to ensure deviations are accurately documented, and resolved prior to closure.
• Work with sites on obtaining necessary information regarding deviations.
• Request Corrective and Preventive Actions (CAPAs) from sites consistent with COG policy.
• Complete the Lead Protocol Organization (LPO) fields on protocol deviation forms in Rave.

Early Closure Forms

• Evaluate early closure requests, complete LPO validation fields, and serve as the primary regulatory contact for site inquiries regarding early closure requests.
• Work with NCI Cancer Trials Support Unit (CTSU), COG membership, COG leadership and sites on site closures or NCI code changes to ensure that study subjects are transferred per COG policies and established SOPs and early closure forms adequately document the required details.

Regulatory Document Collection

• Provide input on site-facing communications regarding required regulatory documents, consistent with COG policy and federal regulations.
• Review and evaluate submitted regulatory documents from sites activating fully industry funded COG trials to ensure compliance with regulatory requirements outlined in the study start up documents.
• Work with sites to obtain any missing documentation.
• Coordinate site registration status changes, ensuring alignment with protocol milestones and federal compliance metrics.
• Respond to questions regarding regulatory document collection and site status changes for fully industry funded COG trials.
• Develop and maintain SOPs, templates and guidance documents for work processes.
• Travel to COG Group Meetings and any other business-related meetings.
• Perform other duties as assigned.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily . The requirements listed below are representative of the knowledge, skill, and/or ability required.

Minimum Qualifications

• Two (2) years experience as a Clinical Regulatory Coordinator, Clinical Trial Auditor, Clinical Trail Monitor or other relevant human clinical trials research experience that includes direct knowledge of FDA Regulations and ICH Guidelines.
• Bachelor’s degree in biology, chemistry, biochemistry, physiology, nursing, or related field, or substitute with four additional years of related experience.

Other Qualifications

• Ability to analyze clinical trial protocols, consent forms and protocol deviation submissions to identify compliance issues.
• Experience with oncology clinical trials.
• Must have knowledge of clinical trial related FDA regulations, ICH-GCP Guidelines.
• High attention to detail and accuracy in document review, data entry, and query resolution.
• Strong organizational skills with the ability to manage multiple regulatory submissions and deadlines simultaneously.
• Ability to work on a team and independently.
• Excellent verbal and written communication skills.
• Ability to maintain confidentiality of sensitive study and participant information.
• Microsoft Office suite and applicable software program(s) proficiency.
• Ability to travel to COG Group Meetings and any other business-related meetings.

Preferred Qualifications

• Demonstrated knowledge of regulatory processes and applicable regulations preferred.
• SOCRA membership preferred.

This position is classified as exempt based on the job duties. However, based on the FTE, salary level of the employee, or federal/state/local laws, the employee may be classified as nonexempt.

Background and Credit Checks

Employment with COG Research Foundation, LLC is contingent upon satisfactory completion of a pre-employment background check, which may include verification of criminal history, employment history, education, and other information as permitted by law. A credit check may be required for positions where it is relevant to and permitted based on the nature of the job duties, in accordance with applicable federal, state, and local laws. All background check results will be evaluated through an individualized assessment in accordance with applicable law. COG Research Foundation, LLC is an equal opportunity employer committed to fair chance hiring practices.

Why Join Us

This is a unique opportunity to be on the ground floor of a critical role within a mission-driven organization. This position will play a vital part in shaping the function of the Children’s Oncology Group, contributing to lasting change and making a difference in the lives of children and families impacted by cancer.

Comprehensive benefit options include medical, dental, vision, 401(k), accrued Paid Time Off (PTO), Employee Assistance Program (EAP), Flexible Spending Account (FSA), cell phone and internet stipends, wellness stipend, paid holidays, and more. Employees who work 20 hours or more per week are eligible for these benefit options. These benefits are provided for informational purposes only and are subject to change in accordance with applicable policies and plan documents.

Equal Employment Opportunity Statement

COG Research Foundation, LLC is an Equal Employment Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and employees without regard to race, color, religion, creed, sex, pregnancy, national origin, age, ancestry, physical or mental disability or medical condition, genetic information, marital status, sexual orientation, gender identity or expression, military or veteran status, or any other characteristic protected by applicable federal, state, or local law.

COG Research Foundation, LLC seeks to recruit, develop, and retain the most talented people from a diverse candidate pool. Employment at COG Research Foundation, LLC is based on merit, competence, and qualifications, and we are committed to providing equal opportunities for training and advancement for all employees. COG Research Foundation, LLC is also committed to making our application process accessible to individuals with disabilities and will provide reasonable accommodation upon request. For further information regarding Equal Employment Opportunity, please feel free to access it here .

ADA/Application Accommodation Statement

COG Research Foundation, LLC is committed to providing reasonable accommodation to individuals with disabilities in the application and employment process, consistent with applicable law. Applicants who require accommodation are encouraged to make their request at the earliest opportunity to allow COG Research Foundation, LLC sufficient time to evaluate and respond to the request. Accommodation requests may be directed to the Recruitment Team at [e-mail].

This position falls under a contract with the Federal Government and is subject to the provisions in OMB Circular A-76 which prohibit contractors from performing inherently governmental functions. Specifically, employees placed in agency positions will not perform inherently governmental functions, nor supervise any personnel other than the contractor’s own staff, nor make final decisions or sign documents that commit the U.S. Government.