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Clinical Trials Nurse Trainer

ABOUT US



Sorrento Therapeutics is a leading biotherapeutics pharmaceutical company with a mission to develop novel therapeutic approaches that extend and enhance cancer patients’ lives, either by reducing the malignancy of life-threatening tumors, improving the safety of current treatments, or by bringing novel solutions to make living with cancer more tolerable. Sorrento is based in San Diego, California, with world class antibody engineering capabilities and a robust early stage pipeline focused on immuno-oncology, infectious disease, and non-opioid pain.



Sofusa® is a Division of Sorrento Therapeutics (www.Sofusa.com) focused on delivering superior therapeutic solutions through lymphatic drug targeting. The Sofusa (“soft infusion”) technology is a disruptive new method of treatment that represents a potential breakthrough in drug development. The proprietary nano-structured microneedle and microfluidics system are designed to access the tiny systemic and lymphatic capillaries just below the epidermis. This unique design offers the potential to deliver therapeutically advantaged drugs by precisely tuning PK profiles and delivering higher concentration of drug into the lymphatics vs traditional injections. This is particularly exciting for the Sorrento pipeline focused on the development of biologic drugs targeting the immune system (e.g. anti-TNFα for autoimmune conditions, anti-PD1 in immune oncology, and T-VIVA vaccine for SARS-CoV-2). In preclinical models, Sofusa has demonstrated the ability to improve efficacy response and/or reduce side effects vs intravenous or subcutaneous administration. In addition, Sofusa’s facility in Sandy Springs, GA leverages unique capabilities in lymphatic imaging and pre-clinical research to support development of translational models in lymphatic drug delivery.



Sorrento Therapeutics, Inc. is a federal government contractor and, in compliance with its obligations under current federal regulations, Sorrento requires all employees, including newly hired employees, to present proof of vaccination against COVID-19 by December 8, 2021, unless the employee is legally entitled to an accommodation. For further information, please refer to the Safer Federal Workforce Task Force’s September 24, 2021 Guidance for Federal Contractors and Subcontractors, available at: https://www.saferfederalworkforce.gov/contractors/.



WHAT WE ARE LOOKING FOR:



Sofusa is seeking an experienced Clinical Nurse Trainer. This position will be responsible for ensuring successful execution of Sofusa clinical studies. The Sofusa lymphatic drug delivery system is very novel with the potential to dramatically change clinical outcomes. Proper translation into the clinic (at the direction of the Sofusa Chief Technology Officer) and execution of Sofusa clinical programs (at the direction of the VP of Clinical Operations) will be critical for successful clinical research and development.




WHAT YOU’LL DO:



Build and execute processes, procedures and capabilities needed to effectively execute Sofusa device clinical studies. Conduct hands on site training and certifications for Sofusa clinical studies. Ensure a certified trainer (self or others) is present at every Sofusa application. Provide clinical expertise and input into design requirements of devices for clinical and commercial use. Be an expert voice and advocate for clinicians and patients during the device design process and in Design Control meetings. Proactive communications and relationship management with the Sofusa clinical sites (program lead, nurses, pharmacy, etc.). Ownership for managing and maintaining Sofusa study material inventory at clinical sites (e.g., devices, drug, supplies). Participate in weekly clinical operations program management meetings. In coordination with the CRO and Sorrento Clinical Operations, identify and share best practices for recruiting, data management, safety monitoring and reporting etc. Provide feedback to clinical research, clinical operations and device manufacturing to improve upon Sofusa clinical program execution. Ensure qualification of those who will be administering investigational drug using the Sofusa device. This includes oversight of contract trainers and CRO’s. Maintain all training certifications. Ensure compliance with device quality assurance and regulatory guidelines during clinical studies and in the development of documentation.

EDUCATION AND QUALIFICATIONS:



BS Nursing or allied health professional required. 5+ years expertise in medical practice. Experience executing clinical trials required. Clinical execution of complex device clinical studies preferred. Strong understanding of clinical trial sites and criteria/processes for selecting and qualifying clinical trials sites. Strong verbal and written communication skills with attention to detail in writing content (e.g. IFU’s, training manuals) and in review of other’s work. Experience in medical writing desired. Strong program management with problem-solving and conflict resolution skills. Experience with imaging and assay methods preferred. Strong interpersonal skills, passionate, a collaborative team player who recognizes input from others is an opportunity to learn and to grow. Ability to function in a lean, fast paced and dynamic start up environment. Proven ability to work independently, meet deadlines and be results-oriented. Flexible with ability and desire to travel to sites up to 50% of working hours (peaks during clinical studies) Be passionate, be flexible, enjoy the experience. This is a unique opportunity and role with a fast growing biotech company with significant opportunity for learning and career growth.

YOUR REWARD:



Earn a competitive salary that allows you to focus your attention on your passion. A comprehensive benefits package including: medical, dental, vision, life and disability insurance, matching 401k, company paid holidays, and Flexible PTO, plus stock options.

If this sounds like the right career to fit your personality and interests, please apply, we’re looking forward to meeting you!



Principals only. Recruiters, please don't contact this job poster.



Sorrento Therapeutics, Inc. is an Equal Opportunity Employer


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