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Weill Cornell Medicine · 7 hours ago

Clinical Research Specialist-CCTO

Upper East Side

Full-time

Onsite

Entry, Mid Level

$70K/yr - $82K/yr

2+ years exp

Weill Cornell Medicine is a leading institution in healthcare and research, and they are seeking a Clinical Research Specialist-CCTO. The role involves managing clinical research studies, ensuring compliance with regulations, and coordinating trial activities with various stakeholders.

BiotechnologyEducationHealth CareInformation ServicesInformation TechnologyMedical

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

Qualification

Clinical research experienceFDA regulations knowledgeGCP guidelines knowledgeMS Office proficiencySoCRAACRP certificationCritical thinking skillsCommunication skillsOrganizational skillsInterpersonal skillsTeam collaboration

Required

Bachelor's Degree in Science, Healthcare or related field

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 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