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Oncology Clinical Research Operations Manager
2 months ago
WHY 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 Clinical Research Study Manager to contribute to our mission and assist our clients in making a significant impact on patient lives.
Benefits of Working at Vitalief:
- Engage in meaningful work that advances scientific breakthroughs with the potential to improve patient outcomes.
- Experience a PEOPLE FIRST culture that emphasizes both personal and professional development.
- Participate in a collaborative environment that encourages innovative thinking.
- 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.
Key Responsibilities:
- Report directly to the Director of Clinical Research Operations, providing support and establishing workflows for high-quality clinical research activities across various Oncology Phase 2 to 4 trials.
- Ensure all clinical research adheres to Good Clinical Practice (GCP) guidelines and complies with relevant Institutional, State, and Federal regulations.
- Foster collaboration with medical staff, executive personnel, and department heads to enhance services, streamline processes, and cultivate a cooperative work environment.
- Oversee the daily operations of a clinical research team, offering guidance and training tailored to their needs in relation to clinical trial activities.
- Exhibit leadership by analyzing staffing patterns and making recommendations to optimize staff coverage and efficiency.
- Collaborate with management to develop, implement, and assess standard operating procedures that support the clinical research program.
- Ensure that clinical research processes prioritize patient-centered care.
- Conduct regular Quality Assurance audits with the team to verify data accuracy and adherence to research protocols.
- Confirm that research protocols receive Institutional Review Board approval and that all regulatory documentation is completed prior to protocol initiation.
- Work in partnership 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.
Essential Qualifications:
- Bachelor's Degree in a social science or related discipline.
- 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 experience managing licensed medical professionals being a plus.
- Demonstrated leadership and people management capabilities, fostering a positive work environment and possessing strong conflict resolution skills.
- Excellent verbal and written communication skills, with the ability to build cross-functional leadership partnerships.
- Strong organizational and time management skills; a collaborative, energetic, and adaptable professional.
- 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: 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 be vaccinated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.
