Senior Clinical Trial Coordinator: Lead Studies & Compliance

Actalent; United States; Hybrid; USD 48.000 - 58.000; Vollzeit

Benefits dieser Stelle

Medical, dental & vision

401(k) plan

Life Insurance

Short/long-term disability

HSA

PTO / Vacation

Zusammenfassung

Actalent is seeking a Sr Clinical Research Coordinator to lead day-to-day management of clinical trials from startup to closeout in a hybrid Bronx, NY setting. You will coordinate startup, enrollment, visits, data integrity, regulatory submissions, and audits, while mentoring junior staff.

The ideal candidate will have 3+ years of independent trial coordination, strong GCP/FDA/IRB knowledge, and excellent organizational and communication skills to manage competing priorities in a fast-paced

Qualifikationen

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

Aufgaben

• Coordinate all aspects of clinical trial operations, including startup, enrollment, maintenance, and closeout.
• 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.

Kenntnisse

GCP knowledge

FDA regulations

IRB processes

Clinical trial coordination

Participant recruitment

Ausbildung

Bachelor's degree in science/healthcare

Tools

Medidata Rave

REDCap

Jobbeschreibung

Actalent is seeking a Sr Clinical Research Coordinator to lead day-to-day management of clinical trials from startup to closeout in a hybrid Bronx, NY setting. You will coordinate startup, enrollment, visits, data integrity, regulatory submissions, and audits, while mentoring junior staff.

The ideal candidate will have 3+ years of independent trial coordination, strong GCP/FDA/IRB knowledge, and excellent organizational and communication skills to manage competing priorities in a fast-paced