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Regulatory Specialist

3 months ago

New York, United States WCM-Q Full time

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