Title: Clinical Research Specialist
Title: Clinical Research Specialist
Location: Upper East Side
Org Unit: Colorectal Surgery Administration
Work Days:
Weekly Hours: 35.00
Exemption Status: Non-Exempt
Salary Range: $29.26 - $36.65
*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 and mentorship 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.
- Provides assistance for specified investigator-initiated trials.
- Serves as the resource for detailed information on assigned protocols and other investigational research activities.
- 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.
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.
- 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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Nearest Secondary Market: New York City