Senior Clinical Data Coordinator — Hybrid (Bronx)

Actalent

United States

Hybrid

USD 48,000 - 58,000

Full time

11 days ago

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Benefits offered by this job

Medical, dental & vision
Critical Illness, Accident, and 1/2/3
401(k) Retirement Plan Pre-tax and R0-
Life Insurance (Voluntary Life & AD&D)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick)

Job summary

Actalent is seeking a Contract to Hire Clinical Research Coordinator in Bronx, NY. You will drive startup, enrollment, maintenance, and closeout of clinical trials, coordinating IRB submissions and data management with vendors and sponsors.

You will screen and enroll participants, conduct visits, ensure protocol adherence, and mentor junior staff while maintaining regulatory documentation and budgets in a collaborative, deadline-driven team.

Qualifications

  • Bachelor's degree in a scientific, healthcare, or related field.
  • Minimum 3+ years of clinical research coordination experience.
  • Experience managing clinical trials independently.
  • Strong understanding of GCP, FDA regulations, and IRB processes.
  • Experience with patient recruitment, consenting, and study management.
  • Excellent organizational, communication, and project management skills.
  • Ability to manage multiple priorities in a deadline-driven environment.

Responsibilities

  • Coordinate all aspects of clinical trial operations, including startup, enrollment, maintenance, and closeout activities.
  • Screen, recruit, consent, and enroll study participants.
  • Conduct study visits and ensure protocol adherence.
  • Maintain accurate source documentation and electronic regulatory binders.
  • Manage IRB submissions, amendments, continuing reviews, and study correspondence.
  • Prepare for sponsor, FDA, and internal audits/inspections.
  • Serve as the primary point of contact for sponsors, CROs, and investigators.
  • Track subject enrollment, study milestones, and timelines.
  • Monitor study budgets and research-related expenses.
  • Review and resolve data queries within electronic data capture (EDC) systems.
  • Coordinate specimen collection, processing, and shipment when required.
  • Assist with training and mentorship of junior research staff.
  • Ensure compliance with GCP, ICH guidelines, HIPAA, and applicable regulations.

Skills

Clinical research coordination
GCP/FDA regulations
IRB processes
Study management
Communication
Project management

Education

Bachelor's degree in a scientific, healthcare, or related field

Tools

EDC systems

Job description

Actalent is seeking a Contract to Hire Clinical Research Coordinator in Bronx, NY. You will drive startup, enrollment, maintenance, and closeout of clinical trials, coordinating IRB submissions and data management with vendors and sponsors.

You will screen and enroll participants, conduct visits, ensure protocol adherence, and mentor junior staff while maintaining regulatory documentation and budgets in a collaborative, deadline-driven team.

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