Nurse Practitioner/ Sub-Investigator
Inflamax Research Limited - Mississauga, ON
The role of the Nurse Practitioner/ Sub-Investigator in clinical research is a refreshing departure from Hospital or Family Practice. It differs from the traditional NP role as it requires a self-motivated individual with a dynamic perspective. It provides an opportunity for autonomy, skill building, decision making, and leadership. This exciting role involves working with clinical teams to manage multiple concurrent clinical trials. The candidate will have the opportunity to study the development of various new and genericized medications and have an impact on the development of pharmaceutical products and medical devices.
The NP/ Sub Investigator role requires performance of duties in keeping with ICH GCP Guidelines and Inflamax Research Inc. Standard Operating Procedures (SOP). The candidate will perform the duties of a Nurse Practitioner/ Sub Investigator in various Bioequivalence, Phase 1-4 studies, and company/ departmental initiatives. These include but are not limited to:
- Reviewing the study protocol and informed consent form
- Performs medical procedures as outlined in the protocol (ie. Physical exams. MMSE, Pap tests)
- Administer any form of Investigational Product as specified in the protocol
- Evaluate subject’s eligibility for a clinical trial by reviewing the medical history, physical examination, laboratory values, ECG and diagnostic findings, spirometry/ PFT and the study inclusion and exclusion criteria
- Monitor and medically manage subject’s health status and progress during the clinical trial according to the protocol, Inflamax Research Inc. SOPs, and sound clinical judgment.
- Assist and/or direct the study coordinator, study manager, or other study personnel in the functions of a clinical trial
- Participate in any external or internal audit of a clinical trial
- Policy and Standards of Practice/ Standard Operating Procedure (SOP) creation and revision
- Training of clinical staff
- Be on-call after hours if required
- Current Nurse Practitioner license in the Province of Ontario
- Completion of a Narcotics and Controlled substances prescribing course preferred
- Certification in ACLS preferred
- Demonstrate knowledge of or participation in a course on ICH GCP Guidelines is an asset
- Strong and accurate diagnostic skills
- Be able to work in a fast paced environment as well as maintain productivity during less demanding times.
- Must be able to work and learn independently and maintain strong analytical and problem solving skills.
- Must be detail oriented and self-motivated; and have excellent work ethic, organizational skills, efficiency, and ablity to multi-task and prioritize effectively
- Excellent interpersonal and leadership skills
- Strong written and verbal communication skills
- Due to the nature of the research industry, the candidate must be able to accommodate flexible hours and manage changes to work schedule.
Inflamax Research is an equal opportunity employer and supports workforce diversity. We are committed to accommodating applicants with disabilities during the recruitment and selection process. Please notify Inflamax Research if you require accommodation at any time during the process.
We thank all applicants for their interest in Inflamax, however, only those selected for an interview will be contacted.