Oncology Clinical Research Manager

2 weeks ago

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

WHY VITALIEF?
Vitalief is a pioneering 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 dynamic team, committed to our mission of making a significant impact on patient lives.

Benefits of Working at Vitalief:

  • Contribute to groundbreaking scientific advancements that aim to improve patient outcomes.
  • Experience a PEOPLE FIRST culture that emphasizes both personal and professional development.
  • Engage in a collaborative environment that encourages innovative thinking.
  • Enjoy a balanced life with 20 PTO (Paid Time Off) 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 a variety of healthcare options.
Compensation: Competitive salary based on experience.

Work Location: Remote options available.

Key Responsibilities:
  • Support the Director of Clinical Research Operations by establishing workflows and processes for high-quality clinical research activities across various Oncology Phase 2 to 4 trials.
  • Ensure compliance with Good Clinical Practice (GCP) guidelines and relevant Institutional, State, and Federal regulations.
  • Collaborate with medical staff, executive personnel, and department heads to enhance service delivery and promote teamwork.
  • Oversee daily operations of a clinical research team, providing guidance and training tailored to their needs.
  • Exhibit leadership by assessing staffing patterns and making recommendations for optimal resource utilization.
  • Work alongside management to develop and refine standard operating procedures that support the clinical research program.
  • Prioritize patient-centered approaches in all clinical research processes.
  • Conduct regular Quality Assurance audits to ensure data integrity and adherence to research protocols.
  • Facilitate the approval of research protocols by the Institutional Review Board and ensure all regulatory documentation is completed.
  • Collaborate effectively with healthcare professionals and support staff to ensure timely service delivery to patients.
  • Maintain up-to-date knowledge of DHHS, FDA, OHRP, NIH, GCP, HIPAA, IRB, and other relevant guidelines.
Required Qualifications:
  • Bachelor's Degree in a relevant field.
  • A minimum of 5 years of experience in a clinical research setting.
  • At least 3 years of experience in Oncology research.
  • 1-2 years of supervisory experience in a clinical research environment, preferably managing licensed medical professionals.
  • Strong leadership and people management capabilities, with a focus on fostering a positive work culture.
  • Excellent verbal and written communication skills, with the ability to build cross-functional partnerships.
  • Strong organizational and time management skills; a collaborative and adaptable professional.
  • Ability to make independent decisions and thrive in a fast-paced environment with multiple concurrent 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 DEMANDS: This role requires standing, sitting, walking, visual perception, talking, and hearing, with the ability to lift up to 20lbs.

IMPORTANT NOTE: Vitalief collaborates with major medical centers and academic institutions, necessitating annual influenza vaccinations and successful completion of a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis for all on-site personnel.

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