Regulatory Project Coordinator

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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.

PHI was distinguished as one of the top 50 "Best Non-Profit Organizations to Work For" by the Non-Profit Times in a national search.

The Children's Oncology Group (COG), a National Cancer Institute (NCI) supported clinical trials group, is the world's largest organization devoted exclusively to childhood and adolescent cancer research. The COG unites more than 12,000 experts in childhood cancer at more than 220 leading children's hospitals, universities, and cancer centers across North America, Australia, and New Zealand in the fight against childhood cancer. Our goal is to cure all children and adolescents with cancer, reduce the short- and long-term complications of cancer treatments, and determine the causes and find ways to prevent childhood cancer.

The purpose of this job is to ensure administrative audit activities are completed in accordance with NCI timelines and to contribute to the evaluation of audit findings, including support of the Corrective Action Preventative Action (CAPA) program. This position will also monitor the operation of the regulatory audit component of COG audits and the implementation of NCI audit timelines.

This is a time limited, remote, and full-time position that is expected to start in June 2025. At PHI, a time-limited position is defined as regular employment with an expected end date of no more than one year from the beginning of the position. In rare circumstances, time-limited positions may be extended to a maximum total length of up to eighteen (18) months from the start of the employee's original time-limited position.

The Regulatory Project Coordinator will be backfilling a position while the employee is on leave. The end date of the position can change based upon business need. The estimated duration of the position is 6 - 7 months.

Full salary range for this position: $64,542 to $92,421 per year. The typical hiring range for this position is from $64,542 (minimum) to $78,482 (midpoint), based on 100% FTE. The starting salary is determined based on the candidate's knowledge, skills, experience, as well as budget availability.

• Oversee the operation of QA Regulatory Reviews
  
  
  
  1. Conduct regulatory audits, as necessary
  2. Perform regulatory re-audits
  
  
  
  

Schedules audits, selects studies, and completes draft audit report

• Audits
  
  
  
  1. Oversee implementation of NCI audit timelines
  2. Review site case lists
  3. Maintain the NCI Audit database, which includes scheduling audits online, compiling audit findings, entering audit reports, and entering follow-up final reports and action items, as necessary
  4. Participate in review of draft audit reports, work to finalize report in follow up with site and auditors as required
  5. Generate all site letters and response drafts for medical director signature
  6. Maintain audit draft and response review tracking sheet
  7. Track ineligible cases identified at audit, and communicate with study chairs and members as necessary
  8. Manages relationships with auditors
  
  
  
  
• Support the CAPA program
  
  
  
  1. Track Corrective Action Preventative Action Plans (CAPAs)submitted to COGQA
  
  
  
  

Maintains tracking tool and monitors trends

2.Prioritize review of CAPAs by COGQA leadership

3.Ensure close out of CAPAs by completing necessary follow-up

4.Coordinate with and may act as a lead to Audit staff

5.Assist with tracking and development of the COG QA audit schedule

6.Provide coverage for department staff as necessary

7.Remain current with regulatory policies

8.Other duties as required and assigned by Medical Director and Director of QA and Regulatory Affairs

• 3 years' experience in clinical research, with at least 2 years in clinical quality assurance, clinical regulatory compliance and/or clinical trials research experience.
• Bachelor's degree, or substitute with four additional years of relevant experience.

• Bachelor's degree in Regulatory Science a plus.
• Clinical Research Coordinator (CRC) or Regulatory Certification preferred.
• Must be able to communicate in writing using correct grammar and punctuation. This requires excellent written communication skills and proficiency at conveying complex processes in a clear manner.
• Strong critical thinking and reasoning skills.
• Strong interpersonal and collaboration skills.
• Must have good organizational and time management skills and should possess the ability to multi-task multiple projects efficiently.
• Ability to work within and lead a team of peers and subordinates.
• Ability to communicate effectively with a wide range of individuals.
• Should be able to work independently with minimal supervision.
• Must be self-motivated.
• Must possess the ability to act in a professional manner.
• Knowledge of Good Clinical Practices, Code of Federal Regulations relating to clinical trials, and ICH Guidelines; knowledge of HIPPA requirements.

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.

APPLICATION INFORMATION

Interested applicants please apply to this posting and submit a copy of your current resume and a cover letter that highlights your relevant skills and experience and explain why you are the best candidate for this position.

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.

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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 atRecruitment@phi.org.

Additional information about PHI's benefits and compensation offerings can be found here.