Clinical Research Coordinator

Position Overview

At Bio Behavioral Health, a PhaseWell Research site, we are proud of our strong reputation for high-quality trial execution in central nervous system (CNS) studies. We are seeking a detail-oriented and patient-focused Clinical Research Coordinator (CRC) to support the execution of clinical trials.

The CRC is responsible for the day-to-day coordination of assigned clinical studies, ensuring participant safety, high-quality source documentation, and exceptional participant (patient) experience. This role ensures assessments are conducted consistently and in compliance with study protocols.

This role is ideal for a clinical research professional who thrives in a fast-paced, highly regulated environment and is passionate about advancing innovative therapies for patients and families in the therapeutic area we serve. This position works closely with site leadership, research coordinators, and the corporate accounting team to ensure accurate financial reporting, compliance with study budgets and contracts.

Key Responsibilities

Study Coordination & Execution

• Coordinate and conduct primarily patient-facing and related study activities from site initiation through study close-out in accordance with protocol, GCP/ICH guidelines, FDA regulations, IRB requirements, and company SOPs
• Screen, consent, and enroll study participants from surrounding communities; support participant recruitment efforts as needed
• Conduct and support subject visits, including follow-up and retention activities
• Maintain study supplies, equipment, and inventory
• Maintain thorough knowledge of assigned protocols, investigational products, and study requirements

Clinical & Data Responsibilities

• Perform clinical procedures as trained and delegated, including vital signs and laboratory processing
• Accurately document study activities in source documents and electronic systems following ALCOA+ principles (source documents, eCRFs, regulatory binders)
• Track and report adverse events (AEs/SAEs) per protocol and regulatory standards
• Manage investigational product (IP) accountability when applicable
• Resolve data queries in a timely manner
• Document and report adverse events, serious adverse events, and protocol deviations per protocol and regulatory requirements

Regulatory & Quality Compliance

• Maintain complete, accurate, and inspection-ready source documentation
• Support quality management and the data department to prepare for and participate in monitoring visits, audits, and regulatory inspections
• Complete required trainings, certifications, and study documentation timely
• Escalate protocol deviations, noncompliance, or quality concerns promptly

Collaboration & Communication

• Maintain professional, timely communication with investigators, sponsors, CROs, monitors, and Bio Behavioral Health/PhaseWell team members
• Support investigator meetings, site initiation visits, and study-related training sessions
• Assist with recruitment initiatives and community outreach specific as needed

Qualifications

• Bachelor's degree in life sciences, nursing, or related field (or equivalent experience)
• Prior experience in clinical research preferred (1–3+ years typical)
• Knowledge of GCP, FDA regulations, and ICH guidelines
• Strong organizational and time-management skills
• Excellent communication and interpersonal abilities
• Ability to work independently and as part of a team
• Proficiency with EDC systems and Microsoft Office

Preferred Qualifications

• Certified Clinical Research Coordinator (CCRC) or equivalent certification
• Experience with specific therapeutic areas (e.g., CNS, oncology, cardiology)
• Phlebotomy or clinical skills experience (if applicable to site needs)

Work Environment

Clinical research site, hospital, or academic setting. May require occasional evening or weekend hours based on study needs.

Location

On-Site, Toms River