The Physician Assistant reports to onsite Medical Director and one of the major functions of the role is communication and interaction with participants, regulatory bodies, and clinical teams along with other departments within Clinical Pharmacology.
Job Summary:This role will provide an information service and knowledge base on the clinical aspects of clinical trials in Clinical Pharmacology. In addition, incumbent may act as a sub-investigator.
Key Responsibilities:
- Perform physical examinations/medical histories, and other participant assessments as delegated by the Medical Director.
- Interact with regulatory bodies as are relevant to the operations department.
- Assume responsibility as technical advisor to the clinical teams and other departments within Clinical Pharmacology.
- Maintain and further develop facilities and processes relevant to operations.
- May perform clinical feasibility review of new proposals.
- Oversee and direct the development/implementation of quality systems to ensure good clinical practices are maintained.
- Ensure compliance with FDA/GCP/ICH regulations.
- Perform routine study activities as needed.
- May assist operations and client managers with Sponsor visits and interactions as appropriate.
- Ensure safe working practices/environment is employed and maintained. Recommend changes as necessary and justify them in accordance with company policy.
- Attend investigator meetings as appropriate.
- Serves as an educational resource and instructor/trainer for staff.
- And all other duties assigned.
Required Education / Licensures / Certifications:- Graduate of an accredited Physician Assistant Program
- Successfully completed the National Certification Requirements for Physician Assistant (NCCPA) and is currently certified to practice (PA-C) - Licensed in Texas
Experience:- Three to five years hands on clinical care experience
- Research experience a plus
Work Environment: - Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
- Occasional drives to site locations, occasional domestic travel.
- Exposure to biological fluids.
- Personal protective equipment required such as protective eyewear, garments and gloves.
Physical Requirements: - Ability to work in an upright and /or stationary position for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Regular and consistent attendance.
- Varied hours may be required.
Benefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable
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