Clinical Research Specialist-CCTO

Title: Clinical Research Specialist-CCTO  

Location: Brooklyn  

Org Unit: Brooklyn 

Work Days:  

Weekly Hours: 35.00 

Exemption Status: Exempt

Salary Range: $70,000.00 - $82,100.00  

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

Position Summary

Under general direction, the Clinical Research Specialist is responsible for the administration, execution, and overall management of clinical research studies.

Job Responsibilities

• Coordinate clinical trials in compliance with federal regulations, GCP guidelines, and internal policies. Ensures prioritization and execution of protocol procedures. Servers as primary contact for study related issues.
• Responsible for subject management. Works closely with the research team to facilitate the screening, enrollment, and treatment of research subjects in compliance with established regulations and guidelines and internal SOPs.
• Assists with eligibility assessment and informed consent process, as appropriate. Performs central subject registration for specified research studies. Provide clinic support, as needed.
• Responsible for subject tracking in OnCore and assists with verification of research related charges.
• Function as primary liaison with sponsoring agencies and external sites.
• Coordinates site visits and audits of clinical trials in conjunction with all pertinent staff, including: the monitor/auditor, the regulatory office, investigational pharmacy, and investigators.
• Maintains and disseminates accurate listings of active and potential studies to participating investigators. Serves as the resource for information on assigned protocols and other investigational research activities. Facilitates research team meetings.
• Facilitate sample collection, processing and storage activities as required by protocols.
• Prepare deviations and Serious Adverse Events (SAEs) reports for the Institutional Review Board and other agencies. 
• Assists with regulatory submissions, including the Protocol Review and Monitoring Committee (PRMC, the Institutional Review Board (IRB) and ancillary committees, as needed.
• Assist with short-term projects and provide cross-coverage to various research members, as needed.
• Attends conferences and disseminates information to clinical staff.

Education

• Bachelor's Degree in Science, Healthcare or 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.
• Experience with conducting and carrying out protocols and research coordination.
• Research experience in an academic health center with exposure to a team research environment at all levels (senior investigators, nurses, research coordinators, lab technicians).

Knowledge, Skills and Abilities

• Knowledge in Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations, and International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines.
• Excellent communication skills (both verbal and written).
• 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.
• Demonstrated 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.
• Ability to work independently and as part of a team.

Licenses and Certifications

• Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification preferred.

Working Conditions/Physical Demands

• Standard office wo