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About the Role
Under general direction, the Clinical Research Specialist is responsible for the administration, execution, and overall management of clinical research studies.
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.
- Manage subjects, working closely with the research team to facilitate screening, enrollment, and treatment in compliance with regulations and guidelines.
- Assist with eligibility assessment and informed consent process.
- Perform central subject registration for specified research studies.
- Provide clinic support as needed.
- Track subjects in OnCore and assist with verification of research-related charges.
- Act as primary liaison with sponsoring agencies and external sites.
- Coordinate site visits and audits of clinical trials with relevant staff.
- Maintain and disseminate accurate listings of active and potential studies.
- Serve as a resource for information on assigned protocols and investigational research activities.
- Facilitate research team meetings.
- Facilitate sample collection, processing, and storage activities as required by protocols.
- Prepare deviation and Serious Adverse Events (SAEs) reports for the Institutional Review Board and other agencies.
- Assist with regulatory submissions, including PRMC, IRB, and ancillary committees.
- Assist with short-term projects and provide cross-coverage to research members.
- Attend conferences and disseminate information to clinical staff.
Requirements
- 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.
- Ability to treat confidential information with utmost discretion.
- 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.
Skills
- Knowledge in FDA and OHRP regulations, and ICH GCP guidelines.
- Excellent communication skills (both verbal and written).
- Strong communication and interpersonal skills.
- Ability to interact with multiple constituencies and exercise 'people skills'.
- Proficiency with MS Office Suite and database applications.
- Organizational skills and ability to pay close attention to detail.
- Critical thinking and analytical skills.
- Ability to multi-task and prioritize in a fast-paced environment.
- Ability to remain focused despite frequent interruptions.
Location
- Upper East Side
Work Type
- Monday-Friday
- 35.00 hours per week
Experience Level
- 2+ years of clinical research experience
Education Level
- Bachelor's Degree in Science, Healthcare or related field
Salary/Compensations
- $72,800.00 - $80,600.00
Benefits
- Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification preferred.
About the Company
- Cornell welcomes students, faculty, and staff with diverse backgrounds from across the globe to pursue world-class education and career opportunities, to further the founding principle of “any person, any study.”
Equal Opportunity
- No person shall be denied employment on the basis of any legally protected status or be subjected to prohibited discrimination involving, but not limited to, race, ethnic or national origin, citizenship and immigration status, color, sex, pregnancy or pregnancy-related conditions, age, creed, religion, arrest and/or conviction record, military or veteran status, sexual orientation, gender expression and/or identity, an individual’s genetic information, domestic violence victim status, familial status, marital status, or any other characteristic protected by applicable federal, state, or local law.
- Cornell University embraces diversity in its workforce and seeks job candidates who will contribute to a climate that supports students, faculty, and staff of all identities and backgrounds.
- We hire based on merit, and encourage people from historically underrepresented and/or marginalized identities to apply.
- Consistent with federal law, Cornell engages in affirmative action in employment for qualified protected veterans as defined in the Vietnam Era Veterans’ Readjustment Assistance Act (VEVRRA).
- We also recognize a lawful preference in employment practices for Native Americans living on or near Indian reservations in accordance with applicable law.