What are the responsibilities and job description for the Field Clinical Trainer - US position at Rakuten Medical?
Company Profile
Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.
Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.
Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.
Position Summary
The Field Clinical Trainer (FCT) will be a key member of the Medical team with responsibilities to train physicians and support staff to properly perform Rakuten Medical drug product infusions and photoimmunotherapy (PIT) procedures. The Field Clinical Trainer provides feedback documentation from the clinical trial sites to the internal Medical, Clinical and R&D teams at Rakuten Medical regarding product performance. The Field Clinical Trainer may train site personnel with study-related data collection and/or documentation practices. The FCT may present treatment summary updates at internal team meetings, leadership meetings, and at external meetings as needed.
The ideal candidate will have an RN or other technical certification with experience in surgical, interventional radiology, intensive care or radiation oncology settings, and with prior experience in an educator or trainer capacity. Additionally, a working knowledge of Federal Guidelines, Good Clinical Practices, drug development process, and conduct of clinical studies is highly desirable.
The Field Clinical Trainer may be located anywhere in the continental US within a reasonable distance of a major airport, and will report to the Chief Medical Officer. This position will require the ability and the willingness to travel extensively up to 70% time, within the U.S. as clinical study enrollment and caseload activities dictate.
Key Duties and Responsibilities include but are not limited to:
Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.
The expected salary range for this position based in California is $120,000 to $140,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.
We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more for full time employees. We recommend anyone coming onsite to be vaccinated for COVID-19. Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.
Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.
Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.
Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.
Position Summary
The Field Clinical Trainer (FCT) will be a key member of the Medical team with responsibilities to train physicians and support staff to properly perform Rakuten Medical drug product infusions and photoimmunotherapy (PIT) procedures. The Field Clinical Trainer provides feedback documentation from the clinical trial sites to the internal Medical, Clinical and R&D teams at Rakuten Medical regarding product performance. The Field Clinical Trainer may train site personnel with study-related data collection and/or documentation practices. The FCT may present treatment summary updates at internal team meetings, leadership meetings, and at external meetings as needed.
The ideal candidate will have an RN or other technical certification with experience in surgical, interventional radiology, intensive care or radiation oncology settings, and with prior experience in an educator or trainer capacity. Additionally, a working knowledge of Federal Guidelines, Good Clinical Practices, drug development process, and conduct of clinical studies is highly desirable.
The Field Clinical Trainer may be located anywhere in the continental US within a reasonable distance of a major airport, and will report to the Chief Medical Officer. This position will require the ability and the willingness to travel extensively up to 70% time, within the U.S. as clinical study enrollment and caseload activities dictate.
Key Duties and Responsibilities include but are not limited to:
- Provide training to physicians and support staffs on proper drug product storage, handling, preparation, and infusion procedure following protocol design
- Provide intra-procedure proctoring and technical support/guidance for PIT procedures, including fiber and needle size and type selection and placement
- Provide training and guidance on use of Rakuten Medical laser device, including calibration and trouble-shooting
- Assessment and monitoring of physicians' skill levels with PIT procedure.
- Identify and perform retraining, as applicable or requested
- Provide clinical and technical feedback regarding device performance, user ergonomics and suggest design improvements. Similarly, identify improvements in procedure techniques that can reduce time and/or improve ease of use
- Participate in the monthly and quarterly treatment case reviews, generate meeting minutes and next steps. Preparation of training materials (e.g., presentation slides, reference guides)
- Become the go-to expert in the Company on study product infusion and PIT procedures
- Assist and support Clinical Operations in ensuring protocol compliance
- Assist and support site personnel with study-related data collection or documentation practices
- Rakuten Medical is a dynamic environment and each employee may be asked to assist in work areas outside of their usual duties. This is an expectation of every employee and it allows for future growth opportunities.
- BSN, BS in Biomedical Engineering or Health Sciences degree
- RN or other technical certification (as appropriate) preferred
- Surgical, Intensive Care, Interventional Radiology and/or Oncology experience desired.
- Minimum 2-5 years related industry experience
- Prior demonstrated experience in an educator/trainer capacity
- Strong medical and anatomic knowledge
- Ability to work independently
- Excellent oral and written communication skills, Excellent interpersonal and team building skills
- Able to quickly build rapport, credibility, and trust with physicians and operating room, radiology and infusion center staff
- Ability to process and prioritize sensitive complex information and problem solve with good judgment under time constraints
- Decisive, able to give procedural coaching/direction calmly and assertively
- Understanding of regulatory guidelines for adverse event reporting for serious/unexpected events
- Understanding of guidelines for reporting device malfunctions
- Experience with interacting with clinical investigators and medical experts.
- Excellent verbal, written, and interpersonal communication skills (fluency in written and spoken English is required)
Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.
The expected salary range for this position based in California is $120,000 to $140,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.
We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more for full time employees. We recommend anyone coming onsite to be vaccinated for COVID-19. Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.
Salary : $120,000 - $140,000
