Clinical Trial Study Startup Specialist

About the Role

We are seeking an experienced Clinical Trial Study Startup Specialist to 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 Specialist 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 role focuses on coordination and oversight rather than direct execution of startup activities, with CRCs and functional teams retaining responsibility for submissions and operational deliverables.

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.

Qualifications

• 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.

Benefits

• 20 PTO days
• 9 paid holidays
• Company-paid life insurance
• Short- and long-term disability
• 401(k)-retirement plan
• Robust healthcare options

Pay

Salary Range: $75,000 to $90,000 - Based on experience level.

Schedule

• Hybrid role – 2 to 3 days on-site in New Brunswick, NJ
• Limited local travel to other hospital sites

Physical Demands

• Standing, sitting, walking, visual perception, talking and hearing
• Lifting up to 20 lbs

Additional Requirements

Vitalief partners with clients such as major medical centers and academic institutions that often require all on-site resources, including prospective Vitalief consultants, to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.