Field Clinical Trainer - US

Rakuten Medical Inc. - US•San Diego, CA

12h•$120,000 - $140,000

About The Position

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.

Requirements

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)
Ability and the willingness to travel extensively up to 70% time, within the U.S. as clinical study enrollment and caseload activities dictate.

Responsibilities

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.