Lead Clinical Research Coordinator

1 week ago

Newark, New Jersey, United States Vitalief Full time
Position Overview

Why Choose Vitalief?
Vitalief is at the forefront of Healthcare consulting, dedicated to enhancing Research and revolutionizing Clinical Trials. We are in search of a skilled and passionate Senior Clinical Research Coordinator to become a vital part of our outstanding team. This role is designed for a full-time, fully benefited employee who will contribute to our mission of making a significant impact on patient lives.

Benefits of Joining Vitalief:

  • Play a crucial role in advancing scientific research that can transform patient care.
  • Experience a culture that prioritizes personal and professional development.
  • Engage in an environment that fosters innovation and collaboration.
  • Enjoy a healthy work-life balance with 20 PTO days and 9 paid holidays each year.
  • Receive comprehensive benefits including company-paid life insurance, short and long-term disability coverage, a 401K retirement plan, and a variety of healthcare options.

Compensation: Competitive salary based on experience level.

Work Environment: This position requires on-site work five days a week, with the potential for one remote day per week after acclimatization.

Key Responsibilities
  • Collaborate with clinical research leadership and medical staff to execute protocol-specific tasks, including patient screening, test ordering, specimen collection, and documentation of patient responses in various Oncology trials.
  • Act as a communication bridge between the organization, investigators, research team members, and sponsors to ensure timely and coordinated patient services.
  • Maintain comprehensive research records for all patients enrolled in Oncology trials, including consent forms, eligibility criteria, and Case Report Forms (CRF).
  • Assist in site preparation for trials, which includes protocol feasibility assessments, budget discussions, startup meeting coordination, staff training, and preparation of regulatory documents.
  • Schedule and conduct trial visits, ensuring patients are informed and procedures are followed as per protocol.
  • Evaluate and triage study patients for serious adverse events, ensuring proper reporting and documentation according to regulations and protocols.
  • Guide patients in understanding their diagnoses, treatment options, and available resources, including educating them about relevant clinical research studies.
Required Qualifications
  • Bachelor's Degree is mandatory.
  • A minimum of 2 years of experience as a Clinical Research Coordinator, with a focus on patient recruitment, regulatory compliance, and data management.
  • Experience in Oncology clinical research is highly advantageous.
  • Strong understanding of current federal regulations and Good Clinical Practice guidelines.
  • Compassionate demeanor with the ability to communicate effectively with patients.
  • Proven ability to manage multiple trials simultaneously, demonstrating strong organizational and time management skills.
  • Ability to work collaboratively with a diverse team to ensure timely patient services.
  • Strong communication skills, with the ability to escalate issues appropriately.
  • Independent decision-making capability in a fast-paced environment.
  • Proficiency in Microsoft Office applications.
  • Familiarity with EPIC and/or OnCore systems is a plus.

Physical Requirements: The role involves standing, sitting, walking, visual perception, talking, and hearing, with the ability to lift up to 20 lbs.

Important Note: Vitalief collaborates with major medical centers and academic institutions, which may require all on-site personnel to meet specific health and safety requirements.

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