Clinical Research Coordinator

Vitalief Inc. is a consulting firm focused on the research and clinical trial industry. They are seeking an experienced Clinical Research Coordinator to support a long-term observational vascular medical device registry study, collaborating closely with the Principal Investigator to ensure successful study execution and management.

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). and 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

Preferred

Proficiency with EPIC

EPIC proficiency

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

Inoculated annually for Influenza

Successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis

Company

Clinical trial operations consulting, managed services, and workforce solutions

New Brunswick, New Jersey, USA

https://vitalief.com/

Founded in 2021

51-200 employees

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 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

Proficiency with EPIC

Minimum 2 years of clinical research coordination experience, including device, registry, or observational trials; interventional experience a plus.

Required skills

Clinical Research Coordination, Vascular Medical Device Registry Studies, Cardiovascular Research, Regulatory Documentation Management, IRB Submissions, Informed Consent Processes, Participant Interaction, EPIC, Clinical Research Databases, CTMS Systems, Microsoft Office

Preferred skills

Proficiency with EPIC

Experience

2+ years