KEY RESPONSIBILITIES

Study Coordination

• Independently manages multiple clinical research studies across therapeutic areas and phases
• Reviews protocols, schedules participant visits, collects data, and executes study procedures per protocol
• Ensures compliance with IRB, FDA, ICH-GCP, and institutional policies

Participant Management

• Conducts informed consent and monitors participant safety
• Documents adverse events and maintains communication with PI and sponsor
• Supports retention through timely follow-up and engagement

Regulatory & Documentation

• Prepares and maintains regulatory documents, IRB submissions, and study files
• Ensures accurate source documentation, CRFs, and investigational product accountability
• Maintains ALCOA-C documentation standards

Data & Quality

• Performs data entry and query resolution in EDC systems within contracted timelines
• Participates in monitoring visits, audits, and quality reviews
• Identifies deviations and supports CAPA planning

Leadership

• Mentors junior staff including CRCs and Research Assistants
• Trains new staff on SOPs, protocols, and compliance standards
• Collaborates with investigators, sponsors, CROs, and regulatory personnel

QUALIFICATIONS

Required:

• Bachelor's degree in health/science field or equivalent clinical research experience
• 3–5 years clinical research coordination experience
• Strong knowledge of ICH-GCP, GDP/ALCOA-C, and regulatory requirements
• Proven experience with informed consent, study visits, and EDC/CRF management

Preferred:

• Clinical research certification (CCRC, CCRP, ACRP-CP)
• Spanish fluency
• Multi-therapeutic or complex interventional trial experience
• FDA inspection or sponsor audit experience

Skills:

• Medical terminology, strong communication, detail-oriented
• Multitasking in fast-paced environments
• CTMS systems, Google Suite, Microsoft Office