Together, we can beat cancer.
At Varian, we bring together the worlds’ best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions. If you want to be part of this important mission, we want to hear from you.
A successful candidate for this position will contribute to the implementation and conduct of clinical studies supported by Varian, and provide Clinical Operations support to other Varian teams. This individual plays a key role in ensuring that data collected pursuant to the study protocol is timely, accurate, and compliant with both ethical and regulatory requirements.
Responsibilities may include, but are not limited to:
- Oversee initiation, progress, and conduct of U.S. and international clinical studies supported by Varian
- Ensure that clinical studies are conducted in a timely manner and within budget
- Contribute to the selection of clinical study sites. Monitor activities at clinical study sites to ensure compliance with ICH/GCP guidelines, FDA regulations, IRB requirements, SOPs, and study protocols
- Act as liaison between Varian and collaborators at clinical study sites, including investigators and other health care professionals, and maintain a positive rapport with each site
- Conduct formal and informal training for diverse teams at clinical study sites
- Generate clear and concise documentation of visits to and communication with clinical research teams
- Contribute to the management of systems for study data
- Maintain organized and up-to-date study files
- Develop study documents and tools such as CRFs, protocols, consent forms, and study device accountability logs. Develop study and protocol-specific training materials.
- Contribute to preparation of reports for submission to regulatory agencies and clinical evaluations of medical devices
- Visit potential and active study sites, and observe radiotherapy and other clinical procedures, as needed
- Degree/certification in life sciences, health sciences, or a technical field, or equivalent degree/experience (e.g., BS, RN, RT)
- Sense of urgency for completing projects on schedule and at a high quality level
- At least 5 years of experience with clinical studies, monitoring clinical study sites, and managing clinical study files
- Excellent verbal and written communication skills
- Detail-oriented and organize
- Conducts themselves professionally
- Proficient in MS Word and MS Excel
- Ability to travel approximately 50%; may include international travel
Skills, abilities, and other requirements:
- Working knowledge of medical terminology
- Comfortable with technology and scientific/engineering principle
- Comfortable applying problem-solving skills in an environment of gray areas/uncertainty
- Successful history of working in a team-oriented environment, yet able to work independently
- Experience with radiation therapy and/or oncology
- Advanced degree (e.g., MS, PhD, MD, DO)
- Experience with clinical studies of significant-risk medical devices
- Experience reviewing or creating patient medical record
- Proficient-level knowledge of FDA regulations for clinical studies and medical devices, including ICH/GCP guidelines