Together, we can beat cancer.
At Varian, a Siemens Healthineers Company, we bring together the world's 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.
We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.
If you want to be part of this important mission, we want to hear from you.
The Clinical Trial Assistant will ensure clinical trials are conducted and reported efficiently and effectively in accordance with ICH GCP, all applicable regulatory requirements, and internal procedures.
Key Responsibilities
- Support the Clinical Operations team with start-up, maintenance, and closeout of clinical studies (e.g., tracking site readiness, clinical documentation, communication with sites, imaging data archival, shipment of trial supplies)
- Conduct reviews of documentation needed for internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are present and compliant with Good Documentation Practices, Varian SOPs, and US and OUS regulations
- Assist in identifying opportunities and proposing solutions to improve process efficiency within and across Clinical Operations
- Review and process clinical site related invoices, in conjunction with Finance and the study team
- Support the management of trial vendors such as contract research organizations and core labs
- Coordinate with sites for ethics committee (EC) and Institutional Review Board (IRB) submissions, including drafting and negotiating the informed consent
- Support processing/re-anonymization of imaging and other non-EDC data needed for product team
- Support UAT of EDC, ePROs (where applicable) and other clinical trial systems
- May accompany Clinical Research Associates with site visits to assist with monitoring tasks
Qualifications
- Bachelor's degree in related field; 1-3 years related work experience in clinical research (e.g., CRC, CTA, or CRA)
- Experience managing clinical trials within medical device industry is preferred, but not required
- Good computer skills in usage of MS Office Suite required, and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred
- Knowledge of national / regional regulations and industry standards regarding interactions with healthcare professionals required
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Fighting cancer calls for big ideas.
We envision a world without fear of cancer. Achieving this vision takes dedication and commitment from all of us, every single day. That's why we celebrate and value the distinctly beautiful and intersectional identities of each of our employees. We are a mirror of our patient-base, which allows us to innovate. Big ideas come from everywhere, and the best ideas are fostered by our unique individual experiences. At Varian, we encourage you to bring your whole self to work and believe your bold and authentic perspective will help to power more victories over cancer.
TogetherWeFight
Privacy Statement
Equal Employment Opportunity Statement
Varian is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.
EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.
Pay Transparency Non-Discrimination Provision
Varian follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.
The base pay range for this position is
Min $55,200 - Max $94,000
The pay wage range shown is based on the job posting's primary location. Actual compensation packages are based on a wide array of factors, including but not limited to skill set, experience, certifications, and location.
