The Public Health Institute (PHI) is an independent, nonprofit organization dedicated to promoting health, well-being, and quality of life for people throughout California, across the nation and around the world. As one of the largest and most comprehensive public health organizations in the nation, we are at the forefront of research and innovations to improve the efficacy of public health statewide, nationally, and internationally.

The Children’s Oncology Group (COG), a National Cancer Institute supported clinical trials group, is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. The COG unites more than 9,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, New Zealand, and Europe in the fight against childhood cancer. An overarching principle of COG is to ensure that the organization’s structure is optimized to maximize the potential for research that improves the outcome for every successive generation of children with cancer.

Position Summary

The Audit Coordinator, reporting to the Director of QA and Audit, is responsible for the annual COG audit schedule in compliance with the NCI’s Clinical Trials Monitoring Branch (CTMB) guidelines. The position will coordinate, facilitate and expedite the audit processes of the Group. This position will interface with the COG auditors and sites both before and after the audit.

Full salary range for this position: $66,843 to $96,905 per year. The typical hiring range for this position is from $66,843 (minimum) to $81,874 (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 & Responsibilities

• Work with Director of QA and Audit and Auditors to develop the annual audit schedule and assign audits to auditors.
• Schedule audits and enter cases into CTMB AIS. Track all events in the departmental tracking log.
• Communicate with COG auditors to provide them with the necessary site specific information to conduct audits.
• Communicate with institutions to provide instructions and obtain information as necessary to set up and follow through with scheduled audits.
• Provide assistance to institutions with audit-related questions.
• Coordinate submission of DARFs and roadmaps from sites. Follow up as necessary to ensure receipt and appropriate redaction of PII.
• Organize submitted DARFs and roadmaps and provide them to auditors in advance of each institutional audit.
• Prepare letters for completion by Regulatory Project Coordinator.
• Ensure receipt of invoices and expense claims from auditors in a timely manner.
  • Review submitted documents for completeness and follow up with auditors as necessary to facilitate timely payment and reimbursement.
• Review templates and SOPs and revise as appropriate.
• Provide back up to department staff as necessary.
• Performs special projects and other duties as requested.

Minimum Qualifications

• At least 2 years of related work experience in medical, scientific or health related field.
• Bachelor’s degree, or substitute with four additional years of related experience.

Other Qualifications

• Experience in clinical research highly desirable, CRA or CTR preferred.
• Must be well organized, detail oriented and have outstanding verbal and written communication skills.
• Must have excellent interpersonal skills.
• Must be computer literate, particularly in word processing.
• Ability to make independent judgment and take initiative to prioritize work and interact with Group leaders.

FAIR LABOR STANDARDS ACT (FLSA) STATUS

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.

PHI WORKFORCE MANDATORY COVID-19 VACCINATION POLICY

Per the PHI Workforce Mandatory COVID-19 Vaccination Policy, it is a condition of employment for all domestic based employees to be fully vaccinated for COVID-19, unless they are granted a reasonable accommodation under applicable law.

New hires need to provide proof of full vaccination prior to their start date or apply for an exemption/accommodation within three business days after their start date. Depending on the circumstances, new hires who do not comply with this Policy, or who cannot be reasonably accommodated, will either have their employment suspended or terminated. Candidates who are non-compliant will have their offers rescinded.

EEO Statement

The Public Health Institute is committed to a policy that provides equal employment opportunities to all employees and applicants for employment without regard to race, color, sex, religion, national origin, ancestry, age, marital status, pregnancy, medical condition including genetic characteristics, physical or mental disability, veteran status, gender identification and expression, sexual orientation, and to make all employment decisions so as to further this principle of equal employment opportunity. To this end, the PHI will not discriminate against any employee or applicant for employment because of race, color, sex, religion, national origin, ancestry, age, marital status, pregnancy, medical condition including genetic characteristics, physical or mental disability, veteran status, gender identification and expression, sexual orientation, and will take affirmative action to ensure that applicants are offered employment and employees are treated during employment without regard to these characteristics.

For further information regarding Equal Employment Opportunity, copy and paste the following URL into your web browser: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

ADA Statement:

The Public Health Institute is committed to providing access and reasonable accommodation in its services, programs, activities and employment for individuals with disabilities. To request disability accommodation in the application process, contact the Recruitment Team at least 48 hours in advance at Recruitment@phi.org.

#LI-REMOTE

To apply for any position, you must create an account on the Public Health Institute’s job application site. After creating your account, you may search the open positions and apply for the specific position that interests you. Please note, mailed and emailed applications will not be accepted.

We’re so pleased the Public Health Institute is an organization you would like to work with. Do you have questions about this opportunity? If so, email our recruitment team at Recruitment@phi.org.