Title: Regulatory Specialist-CCTO
Title: Regulatory Specialist-CCTO
Location: Lower East Side
Org Unit: Regulatory
Work Days: Monday-Friday
Weekly Hours: 35.00
Exemption Status: Non-Exempt
Salary Range: $38.24 - $46.54
*As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices
Position Summary
Under general direction, oversees the regulatory aspects of clinical trials from start-up through study closeout.
Job Responsibilities
- Coordinates designated protocol submissions for research projects. Prepares and submits necessary documents to the Protocol Review & Monitoring Committee (PRMC), the Institutional Review Board (IRB), and ancillary committees and departments.
- Above may include protocol applications, amendments, continuing reviews, serious adverse events (SAE) reports, protocol exception requests and other items as necessary.
- Works with research team to facilitate enrollment of research subjects in compliance with established regulations and guidelines. Reviews and confirms subject eligibility and regulatory compliance for enrollment. Submits eligibility exceptions to the IRB.
- Ensures maintenance of up-to-date regulatory records in compliance with established regulations and guidelines and internal SOPs .
- Prepares and negotiates consent forms and other subject facing documents with the sponsor and/or contract research organization (CRO) and internal entities, for externally sponsored studies.
- Prepares and submits all regulatory documents to sponsors and/or contract research organizations (CRO).
- Schedules and coordinates site initiation visits, regulatory monitoring visits, and assists with clinical trial audits or inspections.
- Maintains and disseminates accurate listings of active and potential studies to investigators and research teams.
- Provides regulatory assistance for specified investigator-initiated trials.
- Serves as the resource for detailed information on assigned protocols and other investigational research activities.
- Mentors and assists with the training on regulatory processes and procedures.
- Performs other job-related duties as assigned.
Education
- Bachelor's Degree
Experience
2+ years of prior clinical research experience in a healthcare setting or a Master’s degree in regulatory affairs or similar.
Demonstrated knowledge and understanding of clinical research.
Knowledge of the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations and International Conference on Harmonization (ICH) Good Clinical Practice (GCP)
Knowledge, Skills and Abilities
- Excellent oral and written communication skills
- Demonstrated strong communication and interpersonal skills; demonstrated ability to interact with multiple constituencies and exercise "people skills".
- Demonstrated proficiency with MS Office Suite and database applications.
- Demonstrated organizational skills and ability to pay close attention to detail.
- Demonstrated critical thinking and analytical skills.
- Demonstrated ability to multi-task and prioritize in a fast-paced environment.
- Demonstrated ability to remain focus despite frequent interruptions.
- Ability to treat confidential information with utmost discretion.
- Demonstrated ability to exercise standards of professionalism, including appearance, presentation and demeanor.
- Demonstrated ability to work effectively in a collaborative manner with all departmental faculty and staff, as well as other institutional representatives.
- Ability to work independently and as part of a team within a fast-paced working environment.
Licenses and Certifications
- Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification preferred.
Working Conditions/Physical Demands
Cornell welcomes students, faculty, and staff with diverse backgrounds from across the globe to pursue world-class education and career opportunities, to further the founding principle of “any person, any study.” No person shall be denied employment on the basis of any legally protected status or subjected to prohibited discrimination involving, but not limited to, such factors as race, ethnic or national origin, citizenship and immigration status, color, sex, pregnancy or pregnancy-related conditions, age, creed, religion, actual or perceived disability (including persons associated with such a person), arrest and/or conviction record, military or veteran status, sexual orientation, gender expression and/or identity, an individual’s genetic information, domestic violence victim status, familial status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Cornell University embraces diversity in its workforce and seeks job candidates who will contribute to a climate that supports students, faculty, and staff of all identities and backgrounds. We hire based on merit, and encourage people from historically underrepresented and/or marginalized identities to apply. Consistent with federal law, Cornell engages in affirmative action in employment for qualified protected veterans as defined in the Vietnam Era Veterans’ Readjustment Assistance Act (VEVRRA) and qualified individuals with disabilities under Section 503 of the Rehabilitation Act. We also recognize a lawful preference in employment practices for Native Americans living on or near Indian reservations in accordance with applicable law.
Nearest Major Market: Manhattan
Nearest Secondary Market: New York City