Clinical Research Subsite Navigator

Weill Cornell Medical College•New York, NY

2d•Onsite

About The Position

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.

Requirements

Bachelor's Degree
Approximately 3 or more years of related research experience in clinical trial management.
Knowledge of FDA regulations, IRB requirements, Good Clinical Practice, and clinical research databases.

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.