Weill Cornell Medical College Clinical Research Specialist-CCTO in New York, New York
Under general direction, assists in the administration, execution, and overall management of clinical research studies. This Clinical Research Specialist will work closely with research nurses to assist with clinic workflows and manage investigator initiated trials.
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 internal SOPs.
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.
3+ years of prior clinical trials experience in a healthcare setting.
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 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.
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