Regulatory Specialist

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

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

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.

Certified Clinical Research Professional (CCRP) Preferred

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.

Licenses and Certifications

Working Conditions/Physical Demands

Standard office work

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