Clinical Research Coordinator in Newark, New Jersey at Vitalief

ABOUT VITALIEF
Vitalief is a consulting firm built exclusively for the research and clinical trial industry, providing innovative Consulting and Functional Service Provider (FSP) solutions to academic medical centers, health systems, sponsors, CROs, and site networks. By combining deep subject matter expertise with the experience of senior research practitioners, we help organizations accelerate study activation, optimize operations, improve financial performance, and build scalable workforce solutions that reduce costs, increase efficiency, and advance clinical breakthroughs for patients.

POSITION SUMMARY:
We are seeking an experienced Clinical Research Coordinator (CRC) to join Vitalief as a full-time employee with comprehensive benefits. This position will support a long-term observational vascular medical device registry study at a community hospital site in Newark, NJ. The ideal candidate will have a minimum of two years of CRC experience, exceptional attention to detail, a strong interest in cardiovascular research, and the ability to work independently while serving as the primary coordinator for the study.

The CRC will collaborate closely with the Principal Investigator and research leadership to support the successful execution, management, and ongoing operations of the vascular medical device observational registry.

WHY VITALIEF?

• Impactful Work: Contribute to scientific advancements that directly improve patient lives in the field of cardiovascular medicine.
• People-First Culture: Thrive in an environment that fosters growth, innovation, and collaboration.
• Comprehensive Benefits: Enjoy 20 PTO days, 9 paid holidays, company-paid life insurance, short- and long-term disability, a 401(k) retirement plan, and robust healthcare options.
• Work Location: 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).

RESPONSIBILITIES
Study Coordination & Participant Management

• 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.

Clinical Data Management & 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.

Regulatory & Study Compliance

• 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.

Sponsor & Site Operations

• 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.

Contracts & Budget Support

• 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.

PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing.
IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.