Regulatory Specialist

Weill Cornell Medicine; New York (NY); On-site; USD 60,000 - 67,000; Full time

Job summary

Weill Cornell Medicine in New York’s Upper East Side seeks a Regulatory Specialist to oversee regulatory maintenance from study submission through closeout. You will coordinate protocol submissions, ensure regulatory compliance, and support subject enrollment under clinical trial guidelines.

The role requires a Bachelor's degree, ~2 years in clinical research, and strong MS Office/database skills. A Master’s degree may substitute for experience; non-exempt, 35 weekly hours.

Qualifications

• Bachelor's Degree in related field.
• Approximately 2 years of prior clinical research experience in a healthcare setting.
• Master's degree in a related field can be substituted for experience.
• Demonstrated knowledge and understanding of clinical research.

Responsibilities

• Coordinates protocol submissions for research projects and submits documents to CSEC, IRB and committees.
• Facilitates subject enrollment in compliance with regulations and guidelines.
• Reviews subject eligibility and regulatory compliance for enrollment; submits eligibility exceptions to IRB.
• Performs central subject registration for specified studies.
• Reports Serious Adverse Events (SAEs) to IRB and other agencies as required.
• Prepares and submits regulatory documents to sponsor or CRO.
• Maintains up-to-date regulatory records and deadlines.

Skills

Communication skills

MS Office

Organizational skills

Critical thinking

Multitasking

Discretion

Professionalism

Collaboration

Education

Bachelor's Degree in related field

Tools

MS Office Suite

Database applications

Job description

• As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices

Title: Regulatory Specialist

Location: Upper East Side

Org Unit: IBD Clinical Research

Work Days

Weekly Hours: 35.00

Exemption Status: Non-Exempt

Salary Range: $43.30 - $48.41

Position Summary

Oversees the clinical trial regulatory maintenance from study submission through closeout.

Job Responsibilities

• Coordinates all aspects of protocol submission for research projects. Prepares and submits all necessary documents to the Clinical Science Evaluation Committee (CSEC), the Institutional Review Board (IRB) and ancillary committees.
• Works with the research team to facilitate the 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.
• Performs central subject registration for specified research studies.
• Reports all Serious Adverse Events (SAEs) to the Institutional Review Board and other agencies, as required.
• Prepares and submits all regulatory documents to sponsor and/or contract research organization (CRO).
• Ensures maintenance of up-to-date regulatory records and compliance with industry deadlines.
• Provides training to junior and new staff on subject registration and regulatory processes and procedures.
• Maintains and disseminates accurate listings of active and potential studies to participating investigators.
• Serves as the resource for detailed information on assigned protocols and other investigational research activities.
• Provides assistance for specified investigator-initiated trials.
• Coordinates site visits and audits of clinical trials.
• Attends conferences regarding clinical trials and disseminates information to clinical staff.
• Maintains electronic and hard copy files.

Education

• Bachelor's Degree in related field

Experience

Approximately 2 years of prior clinical research experience in a healthcare setting.

Master's degree in a related field can be substituted for experience.

Demonstrated knowledge and understanding of clinical research.

Knowledge, Skills and Abilities

• 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 focused despite frequent interruptions.
• Ability to treat confidential information with utmost discretion.
• Demonstrates 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.

Working Conditions/Physical Demands

Standard office work

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