Clinical Research Regulatory Specialist Profound Autism Research Study and Orphan Disease Center

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A Brief Overview

This position is responsible for assisting with the preparation, review, and submission of all protocols, amendments, informed consent documents, annual reviews, and safety reports to the IRB for a large-scale longitudinal research project spanning multiple departments, including Developmental Behavioral Pediatrics, Neurology, Genetics, and the Center for Autism Research at Children's Hospital of Philadelphia. The role also provides regulatory support to the Orphan Disease Center at the University of Pennsylvania, ensuring consistent regulatory practices across studies. This position leverages experience contributing to the development and submission of IND applications and/or IRB protocols, ensuring compliance with regulatory requirements.

This role assumes a central, key supportive role for all studies. This position will also serve as a central resource for all regulatory matters and may assist in the training of new employees. This role is responsible to ensure standardization of all study regulatory binders. This includes assisting with the creation of regulatory binders for new studies and ensuring that study coordinators maintain updated regulatory binders for all active studies. This position will assist with the off-site storage of all files once a study has completed. This ideal candidate must be knowledgeable on, have full understanding of, and promote good clinical practices (GCP) and will be held accountable for adherence to all policies and procedures surrounding these processes and for maintaining up to date knowledge on these policies from IRB, FDA, ICH, GCP, or other sources.

What You Will Do

• Coordinates study startup activities necessary to begin clinical trial on time and in an efficient manner.
• Maintains working relationship with all personnel who support the regulatory process in order to facilitate efficient study start up and ongoing study conduct
• Investigators
• IRB staff
• Technology Transfer staff
• Sponsor or CRO
• Study coordinators
• Timely turnaround of all documents.
• Benchmark all processes, and maintain compliance of 95% to benchmark
• Collaborate with Study Coordinator to help bring study to a quick start up.
• Maintain site Critical Documents Regulatory Binders per FDA/Sponsor or NIH requirement.
• Maintain binders per protocol for Monitor review
• Meet with monitor during routine coordinator visits, regarding Regulatory notebook compliance, upkeep, etc
• Maintain all study related documents and correspondence
• Maintain lab certifications
• Audit preparation
• Generate all study related documents required from site level
• 1572
• Informed Consent
• Financial Disclosure
• SAE and AE reporting
• Amendments
• Safety information
• Document tracking
• Update and Maintain records for all documents requiring continuing review or renewal.
• Continuing IRB renewals
• Investigator CV's
• Staff CV's & licenses
• Financial Disclosure documents
• Laboratory norms
• Maintain knowledge of changing FDA, NIH and ICH guidelines regarding regulatory requirements and documentation.
• Maintain processes and procedures necessary to support the position of regulatory coordinator and investigator.
• Become knowledgeable regarding CHOP IRB policy / procedures and standards.
• Manage IRB submission process.
• Prepare initial consent draft for presentation, comment & corrections by study coordinator and investigator.
• Prepare initial IRB protocol synopsis for comment and corrections.
• Additional work as required.

Education Qualifications

• Bachelor's Degree Required
• Master's Degree in public health related field Preferred

Experience Qualifications

• At least three (3) years of clinical research, regulatory or related experience Required
• At least five (5) years of clinical research, regulatory or related experience Preferred

Skills and Abilities

• Advanced knowledge of clinical research and regulatory protocols (ICH GCP, HIPAA)
• Advanced knowledge of pediatric clinical research
• Advanced proficiency with office software (Microsoft Office) including word processing and spreadsheet software (Word, Excel)
• Excellent written and verbal communication skills
• Excellent interpersonal skills
• Excellent organizational skills
• Excellent time management skills
• Ability to maintain confidentiality and professionalism
• Ability to work independently with minimal supervision
• Ability to collaborate with stakeholders at all levels
• Ability to be flexible and adaptable to change
• Ability to influence others to accomplish tasks outside of the direct span of control

Licenses and Certifications

• Certified Clinical Research Associate (CCRA) - Association of Clinical Research Professionals (ACRP) - - Preferred
• Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates (SOCRA) - - Preferred

To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine.

Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly. At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.