Travel Clinical Research Coordinator - East Coast

Position Overview

The Travel Clinical Research Coordinator is vital in facilitating new research sites with study initiation and early patient enrollment on the East Coast. This position provides operational assistance during periods of high enrollment or staffing shortages, assuring sites are compliant, prepared, and aligned with study protocols. The role demands collaboration with investigators, sponsors, CROs, and site staff while adhering strictly to regulatory and Good Clinical Practice (GCP) standards.

Key Duties

• Travel to various clinical sites to oversee daily study operations such as patient recruitment, screening, enrollment, and follow-ups.
• Train and support site staff regarding study protocols, procedural expectations, and regulatory compliance.
• Coordinate activities for opening new sites to guarantee readiness for study launch.
• Lead early enrollment initiatives by guiding site teams through startup duties and recruitment goals.
• Independently manage all travel arrangements, documentation, and communication with site stakeholders.
• Ensure sites remain audit-ready and provide assistance during monitoring visits and regulatory inspections.
• Manage entire research protocol lifecycle from initiation to closeout.
• Recruit, screen, consent, and enroll study participants following ethical and protocol standards.
• Schedule and perform study visits and required procedures per protocol and International Council for Harmonisation (ICH) GCP guidelines.
• Accurately collect, maintain, and document study data including source materials.
• Prepare and submit Institutional Review Board (IRB) documents such as amendments, reports, and continuing reviews.
• Ensure precise and timely electronic data capture using EDC systems.
• Act as primary contact for sponsors, CROs, monitors, and regulatory entities during site transitions.
• Maintain regulatory binders compliant with FDA and GCP requirements.
• Monitor and order study supplies as needed.
• Assist in audits, inspections, and monitoring visits.
• Educate participants about study procedures, expectations, and associated risks.
• Participate in study training sessions, site initiations, and investigator meetings.
• Document and monitor site progress through startup, enrollment, and operational phases.
• Provide ongoing operational support to enhance site performance and participant engagement.
• Help onboard and train new site personnel in line with company protocols.

Qualifications

• Bachelor’s degree in health, life sciences, nursing, or related discipline required; alternatively, seven or more years of clinical research coordinator experience may be accepted instead of a degree.
• Certification such as CCRC or equivalent is preferred.
• At least 3 to 4 years of clinical research coordinator experience is mandatory.

Required Skills

• Comprehensive understanding of clinical trial operations from startup through study closure.
• In-depth knowledge of Good Clinical Practice (GCP), Good Documentation Practice (GDP), and ALCOA+ principles.
• Familiarity with electronic data capture platforms such as Medidata Rave, Veeva, Oracle, and clinical trial management systems (CTMS).
• Ability to work independently in fast-paced roles involving frequent travel.
• Strong problem-solving, organizational, and meticulous attention to detail.
• Excellent communication and relationship management abilities with sponsors, CROs, monitors, site personnel, and participants.
• Capability to juggle multiple projects and meet deadlines across several sites.

Working Conditions

• Travel expected up to 75% of the time, including overnight stays and occasional weekend work.
• May involve hands-on patient interaction including phlebotomy, specimen handling, and investigational product management.
• Evening or weekend work may be required depending on study demands.

Physical Requirements

• Must live within roughly 60 miles of a major international airport.
• Ability to occasionally lift items up to 25 pounds.

Equal Opportunity

The employer is committed to equal opportunity, prohibiting discrimination based on race, color, religion, gender identity, sexual orientation, national origin, disability, age, veteran status, or other protected categories.