CCTO Investigator - Initiated Trial Specialist (IIT Specialist)

Job Description - CCTO Investigator - Initiated Trial Specialist (IIT Specialist) (2403174)

Position Summary

The Cancer Clinical Trials Office (CCTO) Investigator-Initiated Trial (IIT) Specialist is an independent, organized, and detail-oriented professional who collaborates closely with investigators and the IIT Manager. The IIT Specialist provides operational support and regulatory management for investigator-initiated clinical research at Stony Brook Cancer Center. Additionally, this role contributes to the design, training, implementation, and regulatory compliance of research projects. Key responsibilities include creating and managing data collection forms and databases, overseeing document versioning, and coordinating with cross-functional research staff across multiple sites.

Duties of an Investigator Initiated Trial Specialist include but are not limited to:

1. Providing administrative oversight of IIT study progress, including drafting administrative sections of research protocols, case report forms, consent forms, and other study documents.
2. Supporting 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.
3. Creating Institutional Review Board (IRB) submissions and managing correspondence across research sites, particularly in single-IRB/multi-site studies.
4. Planning and implementing changes to the research plan in collaboration with the PI and study team.
5. Collaborating with investigators and biostatisticians to ensure data collection meets the objectives of the studies and to create clinical study reports as needed.
6. Working with management to develop Standard Operating Procedures (SOPs), Work Instructions, and Forms.
7. Coordinating operations, data collection, and research staff training at each protocol site.
8. Assisting investigators with protocol disclosures, such as those required for clinicaltrials.gov and the Clinical Trials Reporting Program.
9. Identifying and reporting unanticipated problems to the PI, study team, IRB, FDA, and Data Safety Monitoring Committee (DSMC), as applicable.
10. Assisting in the development of study budgets in collaboration with the IIT and Finance Managers.
11. Collaborating with Quality Assurance programs during research audits and monitoring.
12. Attending and actively participating in Clinical Research Team meetings.
13. Maintaining 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:

Required Qualifications:

1. Bachelor of Science or other advanced healthcare degree
2. At least 3 years of experience with clinical studies in a healthcare setting
3. Knowledge and experience in regulatory guidelines and requirements for the conduct of clinical trials
4. Proficiency in Microsoft Office applications

Preferred Qualifications:

1. Master’s Degree or PhD in a related field
2. Additional experience in clinical research, including medical writing
3. ACRP/SOCRA certification (or equivalent)
4. Experience with multi-site studies
5. Familiarity with industry partners (e.g., pharmaceutical companies, CROs, central laboratories)
6. Experience with IND/IDE submissions to the FDA
7. 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

Special Notes: Resume/CV should be included with the online application.

Posting Overview: This position will remain posted until filled or for a maximum of 90 days. An initial review of all applicants will occur two weeks from the posting date. Candidates are advised on the application that for full consideration, applications must be received before the initial review date (which is within two weeks of the posting date). If within the initial review no candidate was selected to fill the position posted, additional applications will be considered for the posted position; however, the posting will close once a finalist is identified, and at minimal, two weeks after the initial posting date. Please note, that if no candidate were identified and hired within 90 days from initial posting, the posting would close for review, and possibly reposted at a later date.

Prior to start date, the selected candidate must meet the following requirements:

1. Successfully complete pre-employment physical examination and obtain medical clearance from Stony Brook Medicine's Employee Health Services
2. Complete electronic reference check with a minimum of three (3) professional references.
3. Successfully complete a 4-panel drug screen
4. Meet Regulatory Requirements for pre-employment screenings.
5. Provide a copy of any required New York State license(s)/certificate(s).

Failure to comply with any of the above requirements could result in a delayed start date and/or revocation of the employment offer.

*The hiring department will be responsible for any fee incurred for examination.

Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.

If you need a disability-related accommodation, please call the University Office of Equity and Access at (631)632-6280.

Anticipated Pay Range: The starting salary range (or hiring range) for this position has been established as $80,458 - $104,040 / year. The above salary range (or hiring range) represents SBUH’s good faith and reasonable estimate of the range of possible compensation at the time of posting. In addition, all UUP positions have an additional $3,400 for location. Your total compensation goes beyond the number in your paycheck. SBUH provides generous leave, health plans, and state pension that add to your bottom line.

Job Number: 2403174

Official Job Title: TH Instructional Support Specialist

Department/Hiring Area: Cancer Clinical Trials

Schedule: Full-time

Shift: Day Shift

Shift Hours: 9:00 AM - 5:00 PM

Pass Days: Sat, Sun

Posting Start Date: Sep 9, 2024

Posting End Date:

Salary Grade: SL3