Clinical Research Project Associate

Title: Clinical Research Project Associate


Location: Midtown


Org Unit: Multisite IT Operations


Work Days:


Weekly Hours: 35.00


Exemption Status: Exempt

Salary Range: $81,700.00 - $92,300.00


*As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices


Position Summary

The Clinical Research Project Associate oversees all aspects of study coordination and study conduct for multisite investigator-initiated studies with a focus on large, pragmatic clinical trials. This key role will serve as the expert in project operations including study design, study conduct, data management, and quality assurance.

Job Responsibilities

• Aligns w/ key stakeholders both internal & external to manage all study coordination & conduct activities for multisite investigator-initiated studies, in accordance w/relevant regulations, Standard Operating Procedures (SOP), & study specific procedures.
• Serves as the primary contact for external subsites on all project related operational matters.
• Collaborates with WCM Principal Investigator (PI) on project design and development of study protocol and informed consent form (ICF).
• Completes all WCM regulatory submissions including Protocol Review and Monitoring Committee (PRMC), Institutional Review Board (IRB), Data Safety Monitoring Committee (DSMC), and other regulatory agencies as required.
• Coordinates with Clinical Research Subsite Navigators to ensure timely dissemination of new and revised project documents to participating subsites.
• Creates the electronic data capture (EDC) system in collaboration with the developers on protocol-specific database design. Ensures the user interface is intuitive for study team use.
• Generates subsite data completion metrics for distribution to subsite PIs and study teams.
• Develops and implements a project-specific monitoring plan. Performs remote monitoring visits to review data timeliness and accuracy. Issues queries for missing data elements or those requiring follow-up.
• Ensures timely resolution of pending data entry and queries.
• Plans subsite Site Initiation Visits (SIV). Develops presentations, training, and educational materials to ensure successful subsite start up. Provides ongoing training and subsite study team support throughout the course of the project.
• Prepares and presents study metrics, progress, and long-term goals at Steering Committee meetings. Leads project-specific study coordinator meetings.
• Provides ongoing updates and reporting to subsite study teams, WCM PI and internal collaborators. Streamlines and facilitates communications with subsites.
• Performs other related duties as assigned.

Education

• Bachelor's Degree

Experience

Approximately 3 or more years of related research experience in clinical trial management.

Knowledge, Skills and Abilities

• Knowledge of FDA regulations, IRB requirements, Good Clinical Practice, and clinical research databases.

Licenses and Certifications

Working Conditions/Physical Demands

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." No person shall be denied employment on the basis of any legally protected status or subjected to prohibited discrimination involving, but not limited to, such factors as race, ethnic or national origin, citizenship and immigration status, color, sex, pregnancy or pregnancy-related conditions, age, creed, religion, actual or perceived disability (including persons associated with such a person), 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) and qualified individuals with disabilities under Section 503 of the Rehabilitation Act. We also recognize a lawful preference in employment practices for Native Americans living on or near Indian reservations in accordance with applicable law.