Clinical Trial Study Startup Navigator

Vitalief•New Brunswick, NJ

5d•Hybrid

About The Position

We are seeking an experienced Clinical Trial Study Startup Navigator to join Vitalief as a full-time and support a multi-site health system cardiovascular clinical research initiative focused on accelerating industry-sponsored trial activations across a large health system network. The Study Startup Navigator will serve as a central coordinator between Clinical Research Coordinators (CRCs), sponsors, investigators, and internal support teams including Contracts, Finance, IRB, Regulatory, Compliance, and IT. This individual will facilitate communication, track startup progress, identify bottlenecks, and help ensure studies move efficiently through the startup lifecycle. This role is focused on coordination and oversight rather than direct execution of startup activities, with CRCs and functional teams retaining responsibility for submissions and operational deliverables. The ideal candidate will possess strong project management, stakeholder coordination, communication, and organizational skills, along with a solid understanding of clinical trial startup processes within academic medical centers or complex healthcare systems.

Requirements

Bachelor’s degree required (healthcare, life sciences, business, project management, or related field preferred).
Minimum of 5 years of clinical research experience, including 2 years of clinical research experience in study startup, clinical trial operations, and/or clinical trial management.
Strong understanding of the clinical trial startup process within site, Academic Medical Center (AMC), or health system environments.
Demonstrated project management and stakeholder coordination experience across multiple concurrent studies or initiatives.
Strong communication and interpersonal skills with the ability to effectively coordinate across sponsors, investigators, CRCs, Legal, Finance, IRB, and operational teams.
Experience identifying workflow bottlenecks, facilitating issue resolution, and driving cross-functional accountability.
Working knowledge of study startup components including feasibility, contracts, budgets, IRB processes, regulatory requirements, and site activation workflows.
Familiarity with ICH-GCP, HIPAA, and general clinical research regulatory requirements preferred.
Experience using CTMS and/or project management platforms such as OnCore, ClickUp, Smartsheet, Monday.com, or equivalent systems preferred.
Ability to manage competing priorities and maintain organization in a fast-paced, highly collaborative environment.
Proactive, solutions-oriented mindset with strong attention to detail and follow-through.
Prior experience supporting cardiovascular or industry-sponsored clinical trials preferred.
CRC, CCRP, CCRA, PMP, or related certification preferred.

Nice To Haves

Familiarity with ICH-GCP, HIPAA, and general clinical research regulatory requirements
Experience using CTMS and/or project management platforms such as OnCore, ClickUp, Smartsheet, Monday.com, or equivalent systems
Prior experience supporting cardiovascular or industry-sponsored clinical trials
CRC, CCRP, CCRA, PMP, or related certification

Responsibilities

Serve as the central coordination point between CRCs, sponsors, investigators, and internal support teams throughout the clinical trial startup process.
Coordinate and track startup activities including feasibility, contracts, budgets, IRB submissions, regulatory reviews, site qualification visits, and system setup activities.
Monitor startup timelines, identify bottlenecks, and proactively escalate issues to help ensure timely study activation.
Facilitate ongoing communication regarding study status, outstanding action items, dependencies, and activation readiness across all stakeholders.
Partner with CRCs and functional departments while maintaining their ownership of study startup execution activities and deliverables.
Coordinate sponsor communications related to startup timelines, documentation requests, site qualification visits (SQVs), and activation planning.
Maintain startup tracking tools, dashboards, and status reports to support operational visibility and leadership reporting.
Support onboarding coordination for CRCs and help ensure operational readiness across participating sites.
Identify process inefficiencies and support continuous improvement efforts to enhance startup timelines and stakeholder collaboration.