Oncology Clinical Research Manager

1 week ago

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

WHY VITALIEF?
Vitalief is a forward-thinking Healthcare consulting firm dedicated to enhancing Research and revolutionizing Clinical Trials. We are in search of a skilled and passionate Clinical Research Study Manager to become a vital part of our dedicated team, contributing to our mission and that of our clients to make a meaningful impact on lives.

Why Choose Vitalief?

  • Contribute to groundbreaking scientific advancements that can significantly improve patient outcomes.
  • Experience a PEOPLE FIRST culture that emphasizes both personal and professional development.
  • Participate in an inclusive environment that fosters innovation and creativity.
  • Enjoy a healthy work-life balance with 20 PTO days and 9 paid holidays each year.
  • Benefit from comprehensive offerings including company-paid life insurance, short and long-term disability coverage, a 401K retirement plan, and various healthcare options.

Compensation: Competitive salary based on experience.

Key Responsibilities:

  • Report to the Director of Clinical Research Operations, providing support and establishing efficient workflows for high-quality clinical research activities across various Oncology Phase 2 to 4 trials.
  • Ensure all clinical research complies with Good Clinical Practice (GCP) guidelines, as well as relevant Institutional, State, and Federal regulations.
  • Collaborate with medical staff, executive personnel, and department heads to coordinate activities, enhance services, and promote teamwork.
  • Oversee the daily operations of clinical research staff, providing support, guidance, and training tailored to their needs.
  • Exhibit leadership by assessing staffing patterns and making recommendations for optimal staff coverage and utilization.
  • Work closely with management to develop, implement, and evaluate standard operating procedures for the clinical research program.
  • Ensure that clinical research processes prioritize patient-centered care.
  • Conduct regular Quality Assurance audits with the assigned team to verify data accuracy and adherence to research protocols.
  • Ensure research protocols receive Institutional Review Board approval and that all regulatory documentation is completed prior to protocol initiation.
  • Collaborate with physicians, nurses, pharmacy staff, and other relevant personnel to ensure timely and coordinated patient services.
  • Maintain up-to-date knowledge of DHHS, FDA, OHRP, NIH, GCP, HIPAA, IRB, and other applicable guidelines.

Required Qualifications:

  • Bachelor's Degree in a social science or related field.
  • A minimum of 5 years of experience in a clinical research institution.
  • At least 3 years of experience in Oncology research.
  • 1-2 years of supervisory experience in a clinical research setting, with a preference for managing licensed medical professionals.
  • Strong leadership and people management skills, with the ability to create a positive work environment and resolve conflicts effectively.
  • Excellent verbal and written communication skills, capable of forming cross-functional partnerships to achieve objectives.
  • Strong organizational and time management abilities, with a collaborative and energetic approach.
  • Ability to make independent decisions and thrive in a fast-paced environment managing multiple clinical trials.
  • Certification from the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (CCRP) is required.
  • Proficient in Microsoft Office Suite (Word, PowerPoint, Excel).
  • Experience with electronic medical records (EPIC) and Clinical Trials Management Systems (e.g., Velos, OnCore).

Physical Requirements: Ability to stand, sit, walk, perceive visual information, communicate verbally, and hear. Ability to lift up to 20 lbs.

IMPORTANT NOTE: Vitalief collaborates with major medical centers and academic institutions, which may require on-site personnel to be vaccinated annually for Influenza and to pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.

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