Physician Assistant: Clinical Operations
Location: Salt Lake City, Utah
Description: PolarityTE is at present recruited Physician Assistant: Clinical Operations right now, this position will be placed in Utah. Detailed specification about this position opportunity please give attention to these descriptions. Job description
PolarityTE is looking for an enthusiastic and passionate physician assistant to be part of our managerial team within our Clinical Operations Department. The job duties include: supervising Clinical Operations Specialists, assisting with new clinical site acquisition, providing clinical site trainings, maintaining relationships with clinical providers, answering product-related questions after PolarityTE product deployments and interfacing with other divisions within the company (Corporate Operations, Quality, Manufacturing, Legal, Compliance) to ensure a smooth work flow and departmental goals are met in a timely and cost-efficient manner. Additional duties may include responding to patient and provider inquiries regarding in-scope indications of PolarityTE products. This position uses clinical knowledge to help providers gain access to and deploy PolarityTE products in the most efficient and optimal manner in accordance with the standard operating procedures (SOPs) of PolarityTE.
Responsibilities *
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Acquire, oversee and m anage clinical sites to ensure achievement of department objectives, goals, and deliverables within budget and timelines.
Implement product trainings and use of PolarityTE products at clinical sites.
Respond to patient and provider inquiries about in-scope indications of PolarityTE products in a timely and professional manner.
Assist the Director of Clinical Operations with recruiting, training, mentoring and developing Clinical Operations staff members along with Clinical Advisors. Directly responsible to supervise, train, mentor and develop Clinical Operations Specialists.
Lead key departmental innovation and process improvement initiatives to help build internal capabilities and efficiencies with processes, systems and PolarityTE products.
Identify outsourcing strategies across vendor categories.
Assist with development and execution of plans for meetings with clinicians at national and international conferences and co ngresses. Prepare and assist with conference presentations.
Ensure compliance with Good Clinical Practices (GCP), current SOPs and internal policies. Provide assistance with updates to SOPs, training documents and work instructions when necessary.
Assist with the preparation, organization and presentation materials for site initiation visits with the possibility of attending and presenting at clinical site visits.
Ensure the development and coordination of operational plans for multiple clinical studies within or across development programs to include study timeline projections, enrollment plans, site engagement plans, safety plans, monitoring plans, study management plans, issue escalation and resolution plans, communication plans and CRO oversight plans.
Assist in oversight and management of external partners including Clinical Advisors, CROs, laboratories, distributors and other related vendors.
Responsible for the clinical sec tion and overall development update for various reporting documents.
Lead development and execution of overall quality remediation plans for clinical studies. Work closely with Regulatory Affairs and Quality Assurance to ensure alignment on positions regarding quality efforts and plans.
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time.
Required
Minimum 5 years of clinical experience with appropriate clinical background (BA/BS in science, PA-C, NP, RN, or Pharm D - an equivalent combination of experience and education may be considered).
Leadership and project management experience.
Prior work with providers regarding patient care management.
Experience in verbal and written communication, as well as presentation skills.
Preferred
Clinical experience in burn, wound care, surgery, orthopedics/plastic surgery.
Regulatory inspection support experience.
Skills
Ability to effectively communicate with providers and patients.
Strong working knowledge of quality systems, clinical trials processes and medical facility operation including value analysis committees and reimbursement structures.
Management of relationships with clinical site staff, including investigators, study coordinators, as well as other relevant functions.
Management of relationships with business partners such as CROs and other service providers.
Strong interpersonal skills and capacity to communicate within a team and manage internal communications.
Comprehension of clinical study tables and listings to ensure clinical data integrity.
ATTRIBUTES OF POLARITYTE EMPLOYEES
Passionate. Self-star ts and stays highly motivated to achieve aggressive goals. Shares contagious energy and enthusiasm liberally. Maintains an insatiable appetite for progress and excellence.
Humble. Learns , adapts and improves relentlessly. Seeks feedback without insecurity and implements coaching. Recognizes others' contributions gratefully. Approaches work and relationships from a positive perspective .
Integrity-centered. Is trustworthy, truthful and transparent in all aspects of work. Keeps commitments to internal departments. Holds self strictly accountable.
Respectful. Appreciates the benefits of diversity and never discriminates. Remains open to new ideas. Keeps the interest of the overall team top of mind.
Entrepreneurial. Rolls up sleeves and does real work. Sees opportunity and pursues such to the fullest potential. Works quickly, intelligently and flexibly. Dreams big and finds ways to accomplish the impossible.
Equal Employment
PolarityTE is committed to providing equal employment opportunities. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, nationality, ancestry, national origin, sex (including pregnancy), gender, affection or sexual orientation, gender identity or expression, age, familial status, marital status, domestic partnership or civil union status, veteran status, physical, sensory, or mental disability, perceived disability, AIDS and HIV status, atypical heredity cellular or blood trait, liability for service in the Armed Forces, genetic information or any other protected category under federal, state or local laws.
PolarityTE is committed to creating and maintaining a workplace in which all employees have an opportunity to participate and contribute to the success of the business and are valued for their skills, experience, and unique perspectives.
BENEFITS
Competitive salary
Health, Dental, Vision, 401k, and PTO
Fun, rewarding, collaborative work environment with dedicated, respectful colleagues
Talented and innovative team that delivers top-tier work product
Opportunities to make an impact in a rapidly growing company that is paving a new path
CORE POLARITYTE VALUES
Inspired by Complex Simplicity
We appreciate that simplicity drives even the most complex systems â€" we acknowledge and investigate this reality to make ground-breaking discoveries and progress.
Patient and Provider Driven
We employ leading healthcare professionals and draw on their clinical experiences to ensure that the needs of providers and patients are at the center of all our work.
Responsible Leaders
We are committed to leading in every aspect of what we do â€" working deliberately with passion, intellect and integrity both as individuals and as pioneers in regenerative medicine.
Deci dedly Daring
We commit to growing, adapting and seeking better solutions. Innovation comes from recognizing and learning from failure. Everyone fails â€" it is what you make of it that leads to something audacious.
Exceptionally Different
We create new paradigms through diverse thinking, experience and knowledge â€" approaching everything we do from a new and transformative perspective.
Welcome to the Shift!â„¢
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If you were eligible to this position, please deliver us your resume, with salary requirements and a resume to PolarityTE.
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This position will be started on: Thu, 26 Apr 2018 10:24:04 GMT