Clinical Research Subsite Navigator

Title: Clinical Research Subsite Navigator

Location: Midtown

Org Unit: Multisite IT Operations

Work Days:

Weekly Hours: 35.00

Exemption Status: Exempt

Salary Range: $79,400.00 - $87,400.00

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 Subsite Navigator oversees all regulatory, contracting, and financial aspects of site activation and study lifecycle for multisite investigator-initiated studies with a focus on large, pragmatic clinical trials. This key role will serve as the primary contact and liaison across multiple studies for the subsite investigators and study teams to streamline and accelerate the activation process.

Job Responsibilities

Coordinates with key stakeholders, both internal and external, to manage all start-up activities for multisite investigator-initiated studies, in accordance with relevant regulations, Standard Operating Procedures (SOP), and study specific procedures.
Manages and coordinates a high volume of communications between internal collaborators and external subsites.
Provide ongoing updates and reporting to subsite study teams, WCM Principal Investigator (PI) and internal collaborators. Streamlines and facilitates communications with subsites. Monitors site timelines and escalates as needed.
Serves as primary liaison between multisite operations and contracts teams for new and ongoing Clinical Trial Agreements (CTA) across multiple clinical studies.
Coordinates dissemination of regulatory and contract documents for protocol and contract amendments. Responsible for robust regulatory and contract tracking to ensure timely approval and execution of required documents.
Develop, implement, and maintain the Site Activation Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
Maintains Trial Master File (TMF) for all subsites across assigned clinical research studies. Provides Quality Assurance (QA) reviews to ensure compliance with relevant regulations and WCM/NYP SOPs.
Organizes and leads meetings across multifunctional teams. Participates in the Site Initiation Visits (SIV) for subsite activation.
Manages financial tracking database for each subsite in accordance with the executed CTA. Develops subsite invoices with multisite operations team to facilitate invoicing processes for subsites. Responsible for ensuring timely subsite payments.
Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information.
Performs other 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.

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