Clinical Research Specialist
4 weeks ago
We are seeking a highly motivated and organized Clinical Research Specialist to join our team at Weill Cornell Medicine. The successful candidate will be responsible for the administration, execution, and overall management of clinical research studies.
Key Responsibilities- Coordinate clinical trials in compliance with federal regulations, GCP guidelines, and internal policies.
- Ensure prioritization and execution of protocol procedures.
- Serve as primary contact for study-related issues.
- Responsible for subject management, including eligibility assessment and informed consent process.
- Perform central subject registration for specified research studies.
- Provide clinic support as needed.
- Responsible for subject tracking in OnCore and assist with verification of research-related charges.
- Function as primary liaison with sponsoring agencies and external sites.
- Coordinate site visits and audits of clinical trials.
- Maintain and disseminate accurate listings of active and potential studies to participating investigators.
- Serve as resource for information on assigned protocols and other investigational research activities.
- Facilitate 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.
- Assist with regulatory submissions, including the Protocol Review and Monitoring Committee (PRMC) and the Institutional Review Board (IRB).
- Assist with short-term projects and provide cross-coverage to various research members as needed.
- Attend conferences and disseminate information to clinical staff.
- 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.
- 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.
- 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.
- Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification.
Standard office work. Travel may be required.
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