09 Aug
|
Cliantha Research
|
Canada
09 Aug
Cliantha Research
Canada
General Responsibilities:
- Monitor the ongoing safety of Study Participants in house
- Assist in the overall conduct of clinical studies for BE and Phase 1-4 studies including, but not limited to:
- Execution of all aspects of study visits as experience and training allow
- Perform clinical and study procedures as per study protocols, ensuring minimal deviations and proper tracking and reporting when deviations occur
- Interact with Principal Investigator, sponsor, manager and Scientific Director and other study coordinators to ensure all aspects of protocols and study requirements are understood
- Assist in design, implementation and coordination of all aspects of data collection, source documentation and CRF transcription as per protocol, SOPs and ICH/GCP guidelines
- Data entry as required
- Participate in development and execution of Quality Control processes
- Prepare for and support QA audits and sponsor monitoring visits
- Study drug management
- IRBs interactions
- Work with study managers and other members of the study teams to ensure study performance meets or exceeds client expectations
- Participate in Operational kick-off meetings and regular study update meetings
- Ensure study subjects are having the best possible experience while participating in studies conducted at Cliantha Research.
- Assist in development of department SOPs, Equipment Binders, templates; Nurse specific
- Procurement of equipment and supplies as required; Nurse specific
- Participate in training of staff as experience and qualifications permit
- Able to implement and execute emergency measures
- Responsible for adverse drug experience assessment, evaluation, collaboration of medical care,
documentation and follow-up during study conduct or until resolution
- Report abnormal vital signs or unusual adverse events of study participants
- Certified to preform and train all nursing tasks (vitals, ECGs, blood draws, etc.)
- Assist in the design of study and time/ event schedules involving special medical procedures
- Input into safety of study design
- Other clinical procedures as necessary
- Certified to preform, monitor and/or train invasive and non-invasive dosing procedures
- Oversee and coordinate contract nurse/ paramedic training
- Train clinic associates on ECG procedures, manual vital procedures, and assessment skills related to reporting adverse events
- May administer Informed Consent Forms
- Other safety duties as assigned
- Participate in Environmental Chamber validations and maintenance; write validation protocols and reports, conduct validation experiments, maintain appropriate logbooks as needed
- Assist in all aspects of company start up activities as required
- Assist in set up and maintenance of laboratory and EMS system
- Ensure study subjects are having the best possible experience while participating in studies conducted at Cliantha Research.
- Ability to demonstrate authority; troubleshoot situations; and make quick, accurate decisions under pressure
- Capable of representing the company in a professional manner
- Model the core values, policies, and procedures for Cliantha
- Uphold the company mission statement and conduct yourself at all times in a respectful and business-like Be a positive role model for all staff and interact with colleagues in a collaborative way.
- Execute other duties as may be required
Qualifications:
- Licensed and in good standing with the College of Nurses of Ontario
- Currently hospital employed in acute care
- Intensive care unite, coronary care unit or emergency department experience
- 1 year clinical practice with assessment skills
- Current CPR certification required
- Advanced Cardiac Life Support (ACLS) or other emergency experience desired
- Ability to respond to study participant needs (i.e. lifting, crouching, bending, etc.)
- Ability to recognize inconsistencies or abnormalities
- Qualified and positive attitude
- Effective trouble-shooting and decision making skills, able to escalate response to situations when relevant
- Proven solid project planning/ coordination/ management skills
- Strong analytical and problem solving skills
- Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively
- Excellent interpersonal skills
- Strong written and verbal communication skills
Job Type: Part-time
Pay: From $45.00 per hour
Education:
- Bachelor's Degree (preferred)
Experience:
- Registered Nurse: 1 year (preferred)
Licence/Certification:
- Registered Nurse (RN) License in Province of Ontario (required)
Work Location: In person
📌 Registered Nurse (Canada)
🏢 Cliantha Research
📍 Canada