Job Description
ABOUT VITALIEF Vitalief is a consulting and professional services firm that partners with clinical research sites, sponsors, and CROs to enhance trial activation, operational performance, and workforce readiness. Our approach combines deep clinical research expertise with operational excellence and business acumen, enabling organizations to work more efficiently. We help clients streamline processes, reduce costs, accelerate timelines, and ultimately improve patient outcomes.
THE ROLE We are seeking an experienced Clinical Research Coordinator to join our team as a full-time Vitalief employee. In this role, you will support a leading academic research center in Newark, NJ, managing high-priority interventional oncology clinical studies across multiple disease groups.
WHY VITALIEF? - Contribute to advancing scientific discoveries that improve patient lives.
- PEOPLE FIRST culture with opportunities for growth and innovation.
- Competitive benefits including: 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans.
- Work schedule: 5 days per week on-site (Newark, NJ) initially; potential for 1 day remote weekly after acclimation.
- Market-competitive salary, commensurate with experience.
RESPONSIBILITIES: - Under the direction of the Clinical Research Study Site Leader, support the planning, implementation, and execution of multiple concurrent Medical Oncology interventional studies (Phase I–III). Studies are largely drug and biologic trials that may include radiation and surgical components.
- Independently manage day-to-day clinical research activities across the full study lifecycle, from start-up through close-out.
- Collaborate closely with principal investigators, clinical care teams, and ancillary departments (e.g., pathology, radiology, clinical laboratory, surgery, and infusion services) to ensure protocol adherence, patient safety, and compliance with Good Clinical Practice (GCP) guidelines.
- Support investigators in the preparation and activation of new clinical trials, including feasibility assessments, patient screening, enrollment, and ongoing protocol-driven clinical management and retention of study participants.
- Coordinate and conduct participant study visits; maintain study databases; and ensure accurate, timely data collection and entry.
- Manage regulatory documentation, including regulatory binders, IRB submissions, amendments, continuing reviews, and compliance with FDA, IRB, and GCP requirements.
- Identify, assess, document, and report adverse events and serious/unexpected adverse events (SAEs) in accordance with protocol and regulatory requirements.
- Consistently meet or exceed study enrollment and retention targets.
- Monitor participant safety, prepare required study reports, and support sponsor monitoring visits, audits, and inspections.
- Maintain accurate study records within Clinical Trial Management Systems and institutional platforms (e.g., OnCore, Epic, ClinicalTrials.gov), including oversight of research billing reviews.
REQUIRED SKILLS: - Bachelor’s degree required (healthcare, life sciences, or related field preferred).
- Minimum of two (2) years of clinical research coordination experience; academic or institutional research site experience strongly preferred.
- Prior experience supporting oncology clinical trials strongly preferred.
- Phlebotomy certification or willingness to obtain training preferred.
- Working knowledge of GCP, FDA, and IRB regulations and clinical research compliance standards.
- Demonstrated experience with patient recruitment and retention, IRB submissions, data management, and adverse event reporting.
- Excellent written and verbal communication skills, with the ability to interact effectively with investigators, clinical staff, sponsors, and research participants.
- Strong organizational and time-management skills; ability to manage multiple studies and competing priorities in a fast-paced environment.
- Proactive, adaptable, and self-motivated, with strong critical thinking and prioritization skills.
- Compassionate, professional demeanor with strong patient-facing skills and the ability to translate complex clinical information into clear, patient-friendly language.
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
- Experience with Electronic Health Records (Epic preferred) and Clinical Trial Management Systems (OnCore preferred).
PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs.
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.
Job Tags
Full time, Temporary work, Work at office, Remote work,