1. Assesses and ensures subject safety during trial.
2. Proposes and negotiates alternatives for protocol. Educates staff about the scientific aspects of the study.
3. Applies pharmacological knowledge to help PI determine idiosyncrasies and unexpected results. Evaluates adverse events (AE), intervenes when necessary and reports details to PI. Conducts follow-up to determine resolution of AE. Reports serious AEs to IRB and sponsor.
4. Presents related information to community for recruitment purposes or to other research professionals in a variety of settings.
5. Mentors and trains new and subordinate employees.
6. Helps determine personnel required to complete trial and develop the timeline for trial completion. Reviews study related data to assure compliance with study protocol.
7. Prepares emergency use report.
8. Manages pharmacokinetic collection and storage.
9. Relates lab results to PI and sponsor.
10. Ensures appropriate maintenance and calibration of equipment.
11. May perform bedside care.
This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
Work Environment and Level of Frequency that may be required:
Nearly Continuously: Office environment.
Often: Infectious disease, oils (there is air or skin exposure to oils or other cutting fluids), hazards (includes a variety of physical conditions, such as proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, or exposure to chemicals).
Physical Requirements and Level of Frequency that may be required
Nearly Continuously: Hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking, standing, sitting.
Seldom: Bending, reaching overhead.
The staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her assigned unit. The individual must demonstrate knowledge of the principles of life span growth and development and the ability to assess data regarding the patient’s status and provide care as described in the department’s policies and procedures manual.
