Posting Number: #195-21
Position Title: Regulatory Project Coordinator
Closing Date: Until Filled
Location: Monrovia, CA / Remote
Children’s Oncology Group (COG), a project of PHI, is a National Cancer Institute (NCI) supported clinical trials cooperative group, and the world’s largest organization devoted exclusively to childhood and adolescent cancer research. Clinical research is conducted at more than 200 member institutions, which are leading children’s hospitals, universities, and cancer centers throughout the United States, Canada, Europe, Australia, and New Zealand. COG’s over 9,000 multi-disciplinary cancer researchers, affiliated with the network of member institutions, provide access to state-of-the-art therapies and the collective expertise of world-renowned pediatric specialists to children with cancer, regardless of where they live. Today, more than 90% of 14,000 children and adolescents diagnosed with cancer each year in the US are cared for at Children’s Oncology Group member institutions.
The Project Coordinator, reporting to the Director of Quality Assurance and Audit, will be responsible for managing the preparation, submission and maintenance of regulatory documents required for COG-sponsored clinical trials. In collaboration with COG study committees s/he will serve as an internal coordinator for all regulatory IND/IDE projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
- Prepare and submit regulatory documentation including IND/IDE applications, FDA annual reports, serious adverse event reports, amendments etc. to the appropriate regulatory agencies, including the FDA.
- Maintain and track regulatory files and records.
- Ensure project documents are complete, current, and stored appropriately.
- Interface with COG’s study development office and industry sponsored trials department to ensure timely submission of regulatory documents in compliance with NCI’s OEWG timelines.
- Monitor weekly postings for COG-sponsored studies to determine regulatory implications of study progress.
- Serve as a primary contact for all communication regarding regulatory issues on COG sponsored studies both internally (COG study committees) and externally (regulatory agencies).
- Review and distribute incoming adverse event reports to study committees along with a preliminary assessment of the sponsor’s reporting obligations to the FDA
- Assist with review and submission of safety reports to regulatory authorities
- Suggest and implement process improvements to better meet research and operational goals
- Develop and maintain Standard Operating Procedures.
- Serve as back-up for other staff in the department.
- 3 years related experience required. 2 years of experience in clinical quality assurance, clinical regulatory compliance or clinical trials research experience highly preferred.
- Demonstrated organization and time management/prioritization skills with the ability to work independently are required.
- Must be competent in all components of Microsoft Office Suite
- Excellent written and oral communications
- Strong interpersonal and collaboration skills
- Ability to communicate effectively with a wide range of individuals
- Must possess the ability to act in a professional manner
- Strong critical thinking and reasoning skills
- Bachelor’s degree in science, nursing or related field is required, or substitute with four additional years of related experience.
Required for satisfactory performance in this job is knowledge of Good Clinical Practices; Code of Federal Regulations relating to clinical trials, and ICH Guidelines. Regulatory certification is preferred.
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.
- This is a full-time (40 hours per week) position.
- To qualify for this position, applicants must be legally authorized to work in the United States.
- Our Office is currently closed due to COVID-19 through December 2021. We are currently working remotely and we expect this position will have remote workplace flexibility beyond December 2021.
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.
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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 at Recruitment@phi.org.