CCTO Investigator Specialist

7 days ago

Stony Brook, New York, United States Stony Brook Medicine Full time
Job Summary

The Cancer Clinical Trials Office (CCTO) Investigator-Initiated Trial (IIT) Specialist is a critical role that requires a detail-oriented and organized professional to collaborate closely with investigators and the IIT Manager. This position provides operational support and regulatory management for investigator-initiated clinical research at Stony Brook Cancer Center.

Key Responsibilities
  • Provide administrative oversight of IIT study progress, including drafting administrative sections of research protocols, case report forms, consent forms, and other study documents.
  • Support investigators with FDA correspondence to ensure compliance with federal regulations for institutionally or Principal Investigator (PI)-held Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications.
  • Create Institutional Review Board (IRB) submissions and manage correspondence across research sites, particularly in single-IRB/multi-site studies.
  • Plan and implement changes to the research plan in collaboration with the PI and study team.
  • Collaborate with investigators and biostatisticians to ensure data collection meets the objectives of the studies and to create clinical study reports as needed.
  • Work with management to develop Standard Operating Procedures (SOPs), Work Instructions, and Forms.
  • Coordinate operations, data collection, and research staff training at each protocol site.
  • Assist investigators with protocol disclosures, such as those required for and the Clinical Trials Reporting Program.
  • Identify and report unanticipated problems to the PI, study team, IRB, FDA, and Data Safety Monitoring Committee (DSMC), as applicable.
  • Assist in the development of study budgets in collaboration with the IIT and Finance Managers.
  • Collaborate with Quality Assurance programs during research audits and monitoring.
  • Attend and actively participate in Clinical Research Team meetings.
  • Maintain research practices in accordance with Good Clinical Practice (GCP) guidelines, ensuring strict patient confidentiality as per HIPAA regulations and applicable law, and ensuring compliance with all federal and local agencies, including the FDA and local IRB.
Qualifications
  • Bachelor of Science or other advanced healthcare degree
  • At least 3 years of experience with clinical studies in a healthcare setting
  • Knowledge and experience in regulatory guidelines and requirements for the conduct of clinical trials
  • Proficiency in Microsoft Office applications
Preferred Qualifications
  • Master's Degree or PhD in a related field
  • Additional experience in clinical research, including medical writing
  • ACRP/SOCRA certification (or equivalent)
  • Experience with multi-site studies
  • Familiarity with industry partners (e.g., pharmaceutical companies, CROs, central laboratories)
  • Experience with IND/IDE submissions to the FDA
  • Knowledge of policies and procedures governing clinical research and research subject protection, including US Federal Regulations, FDA guidelines, International Council for Harmonisation, Good Clinical Practices, HIPAA, NCI, and NIH regulatory and research disclosure requirements

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