Regulatory Specialist

Socket.dev; New York (NY); On-site; USD 59,000 - 66,000; Full time

Job summary

Cornell University on the Upper East Side seeks a Regulatory Specialist to oversee regulatory maintenance for clinical trials from submission through closeout. You will coordinate submissions to IRB/CSEC, ensure subject enrollment complies with regulations, and maintain accurate regulatory records in a fast-paced healthcare setting.

The role requires a Bachelor's degree with ~2 years' clinical research experience; CCRP is preferred.

Qualifications

• Bachelor's degree in a related field required.
• Approximately 2 years of clinical research experience.
• CCRP certification preferred.
• Strong regulatory and documentation skills.

Responsibilities

• Coordinate protocol submission for research projects and prepare regulatory documents for IRB and CSEC.
• Facilitate enrollment of research subjects in compliance with regulations.
• Review eligibility and submit exceptions to IRB.
• Perform central subject registration for studies.
• Report SAEs to IRB and agencies as required.
• Prepare and submit regulatory documents to sponsor and/or CRO.
• Maintain regulatory records and ensure deadlines.
• Train junior staff on registration and regulatory processes.
• Maintain study listings and disseminate information to investigators.
• Coordinate site visits and audits of clinical trials.
• Attend conferences and disseminate information to staff.
• Maintain electronic and hard copy files.

Skills

Regulatory knowledge

Communication skills

MS Office Suite

Attention to detail

Multi-tasking

Professionalism

Team collaboration

Education

Bachelor's Degree in related field

Tools

MS Office Suite

Database applications

Job description

Title: Regulatory Specialist

Location: Upper East Side

Org Unit: Neurological Surgery

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.

Working Conditions/Physical Demands

Standard office work

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