Description

Title: Clinical Research Specialist-CCTO

Location: Upper East Side

Org Unit: Cancer Clinical Trials Office

Work Days: Monday-Friday

Exemption Status: Exempt

Position Summary

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

Job Responsibilities

Ensures clinical trial compliance with federal regulations, GCP guidelines, and internal policies. Ensures prioritization and execution of protocol procedures.

Develops a familiarity with study protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections. Serves 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.

Conducts eligibility assessment and obtaining written informed consent, as appropriate. Performs central subject registration for specified research studies. Provides clinic support, as needed.

Responsible for subject tracking in OnCore and assists with verification of research related charges.

Functions as primary liaison with sponsoring agencies and external sites. Performs 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. Oversees study inventory including acquisition and disposal of study related materials.

Prepares deviations and Serious Adverse Events (SAEs) reports for the Institutional Review Board and other agencies.

Develops study related documents in accordance with SOPs/study specific processes. Assists with regulatory submissions, including Protocol Review and Monitoring Committee (PRMC), Institutional Review Board (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.

Education

Bachelor's Degree in related field

Experience

Bachelor's Degree in Science, Healthcare, or a related field.

Approximately 2+ 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.