Clinical Research Coordinator

Responsibilities

• Manage day-to-day study activities as the primary site coordinator, working directly with the PI.
• Identify, screen, consent, enroll, follow-up with study participants (health check calls).
• Maintain accurate source documentation.
• Review participant records in EPIC to support study requirements and clinical data collection.
• Complete case report forms (eCRFs), perform data entry, and resolve data queries.
• Ensure accuracy, completeness, and compliance of study documentation.
• Maintain essential regulatory documents, including investigator files, training records, licenses, and delegation logs.
• Support IRB submissions, continuing reviews, amendments, and regulatory correspondence.
• Ensure ongoing compliance with protocol requirements, GCP, and research standards.
• Serve as a primary contact for sponsors, CROs, IRBs, and internal research teams.
• Support monitoring visits, site meetings, issue resolution, maintain study readiness and study closeout activities.
• Assist with clinical trial agreement (CTA) coordination and budget-related activities.
• Collaborate with legal, finance, and sponsor teams to support study operations.

Qualifications

• Bachelor's degree in health science, life science, nursing, or related field.
• Minimum 2 years of clinical research coordination experience, including device, registry, or observational trials; interventional experience a plus.
• Experience managing regulatory documentation, IRB submissions, informed consent processes, and participant interaction.
• Proficiency with EPIC (preferred), Microsoft Office, and clinical research databases/CTMS systems.
• Ability to work effectively as the primary coordinator at a research site with limited day-to-day oversight.
• Strong organizational skills with the ability to independently prioritize and manage multiple responsibilities.
• Sharp attention to detail and commitment to research compliance and data quality.
• Self-starter who thrives with minimal oversight, communicates effectively across leadership, investigators, sponsors, and cross-functional teams, and proactively resolves issues.

Benefits

• 20 PTO days
• 9 paid holidays
• Company-paid life insurance
• Short- and long-term disability
• A 401(k) retirement plan
• Robust healthcare options
• Hybrid 2-3 days per week onsite in Newark, NJ, with flexibility for remote work on remaining days
• Salary Range: $65,000 to $78,000 (depending on experience level)