Title: Clinical Research Specialist-CCTO
Location: Upper East Side
Org Unit: Pediatrics
Exemption Status: Non-exempt
Under general direction, assists in the administration, execution, and overall
management of clinical research studies.
Coordinates clinical trials in compliance with federal regulations, GCP
guidelines, and internal policies.
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
Assists with eligibility assessment and obtaining written informed
consent, 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.
Functions as liaison with sponsoring agencies and external sites.
Coordinates site visits and audits of clinical trials in conjunction with
all pertinent staff, including: monitor/auditor, 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.
Facilitates sample collection, processing and storage activities as
required by protocols.
Prepares deviations and Serious Adverse Events (SAEs) reports for
Institutional Review Board (IRB) and other agencies. Assists with
regulatory submissions, including Protocol Review and Monitoring Committee
(PRMC), IRB and ancillary committees, as needed.
Provides training and mentorship to junior and new staff.
Assists with short-term projects and provide cross-coverage to various
research members, as needed.
Attends conferences and disseminates information to clinical staff.
Bachelor's Degree in related field
Bachelor's Degree in Science, Healthcare, or a related field.
Approximately 2+ years of prior clinical trials experience in a healthcare
Experience with conducting and carrying out protocols and research
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
Demonstrated proficiency with MS Office Suite and database applications.
Demonstrated organizational skills and ability to pay close attention to
Demonstrated critical thinking and analytical skills.
Demonstrated ability to multi-task and prioritize in a fast-paced
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
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 work.
Travel may be required.
Weill Cornell Medicine is a comprehensive academic medical center that's
committed to excellence in patient care, scientific discovery, and the
education of future physicians in New York City and around the world. Our
doctors and scientists-faculty from Weill Cornell Medical College, Weill
Cornell Graduate School of Medical Sciences, and the Weill Cornell Physician
Organization-are engaged in world-class clinical care and cutting-edge
research that connect patients to the latest treatment innovations and
prevention strategies. Located in the heart of the Upper East Side's
scientific corridor, Weill Cornell Medicine's powerful network of
collaborators extends to its parent university Cornell University; to Qatar,
where an international campus offers a U.S. medical degree; and to programs in
Tanzania, Haiti, Brazil, Austria and Turkey. Our medical practices serve
communities throughout New York City, and our faculty provide comprehensive
care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-
Presbyterian/Lower Manhattan Hospital, and NewYork-Presbyterian/Queens. At
Weill Cornell Medicine, we work together to treat each individual, not just
their conditions or illnesses, as we strive to deliver the finest possible
care for our patients - the center of everything we do. Weill Cornell Medicine
is an Equal Employment Opportunity Employer. Weill Cornell Medicine provides
equal employment opportunities to all qualified applicants without regard to
race, sex, sexual orientation, gender identity, national origin, color, age,
religion, protected veteran or disability status, or genetic information.