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 IND 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
- 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 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.
- 3 years related experience, with at least 2 years of experience in clinical quality assurance and/or clinical regulatory compliance.
- Bachelor’s degree in science, nursing or related field.
- Knowledge of Good Clinical Practices; Code of Federal Regulations relating to clinical trials, and ICH Guidelines.
- 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.
- Regulatory certification.
- 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.