Senior Regulatory Affairs, Study Start Up Specialist

Essential Functions:

• Perform/ oversee compliance assessments against Food and Drug Administration (FDA) lists and documents any FDA activity discovered; notifies Study Manager of any FDA activity documented per CTI SOPs.
• Compile/ oversee site Regulatory binders being developed, according to CTI SOPs or Sponsor PSOP, performs QC review of binders and ships binders to sites.
• Perform/ oversee Central IRB submissions on behalf of Sponsors and sites as agreed to in the scope.
• Review and comment on informed consent form (ICF) modifications per Sponsor and site requirements for all types of consent forms used during each study (assents, pharmacokinetics [PK], pharmacodynamics [PD], pharmacogenomics [PG], Parental, Health Insurance Portability and Accountability Act of 1996 [HIPAA], etc.).
• Update ICF content when amendments or study changes require ICF changes and/or modifications.
• Receive and process study documentation from the sites, assessing content quality for accuracy and completeness.
• Interact with site personnel for document corrections, clarification, or resolution of any incomplete and/or incorrect documentation.
• Interact with Sponsors as needed, forwarding Regulatory documentation to Sponsors according to CTI SOPs, Sponsor PSOPs or scope.
• Provide Study Teams with accurate periodic status reports of in-house documentation.
• Maintain all essential Regulatory documents so that dated documents do not expire throughout the life of each study.
• Perform review, reconciliation, close-out and archiving activities of study documentation according to CTI SOPs, Sponsor PSOPs or scope
• Train and mentor less experienced Regulatory staff and other CTI functional department staff regarding regulatory work.
• QC and QA of various study related Regulatory documents and reports.
• Represent the Regulatory department in capabilities and bid defense presentations.
• Prepare for Sponsor or Agency audits and inspections.
• Accurately name, process and upload or file all content complete and correct documents in the TMF, whether electronic or paper, and apply the required metadata to result in correct auto filing of all electronic documents and/or manual filing of hard copies in paper files.

Required Education/Experience:

• Bachelor Degree in allied health field such as nursing, pharmacy, or health science or the equivalent relevant experience.
• At least 5 years relevant pharmaceutical or CRO Regulatory experience
• Strong working knowledge and understanding of FDA, Good Clinical Practice (GCP) / International Council for Harmonisation (ICH) regulations and guidelines.

Competencies:

• Ability to work well in a team environment
• Ongoing willingness to learn
• Detail oriented
• Excellent verbal and written communication skills
• Ability to develop, prioritize, organize, and manage multiple tasks
• Ability to provide superior level of customer service
• Proficient in use of computer and software systems
• Ability to maintain confidentiality
• Strong understanding and application of principles, concepts, practices, and standards of CRO industry.

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com