INFLAMAX RESEARCH INC Clinical Research Coordinator (Part-Time) Part Time in Mississauga, ON

Overview

INFLAMAX RESEARCH INC

Branch Mississauga ON CA

Position:
Clinical Research Coordinator (Part-Time)
Location:
Mississauga, ON

Participate in Environmental Chamber validations and maintenance; Assist in the overall conduct of clinical studies for BE and Phase 1-4 studies including but…

General Responsibilities:
Assist in the overall conduct of clinical studies for BE and Phase 1-4 studies including but not limited to:

• Recruitment, screening, and coordination of patient visits as per study protocols
• 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
• Lab Sample processing, labelling, storage, shipment, documentation and record keeping
• IRBs interactions
• Site Regulatory Documentation collection and management
• Archiving
• 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 Inflamax Research Inc.
• Under supervision of manager, may act as study lead
• Assist in development of department SOPs, Equipment Binders, templates
• Procurement of equipment and supplies as required
• Calibration and maintenance of equipment per SOPs; Maintain appropriate logbooks
• Participate in training of staff as experience and qualifications permit
• Participate in Environmental Chamber validations and maintenance; write validation protocols and reports, conduct validation experiments, maintain appropriate logbooks
• Assist in all aspects of company start up activities as required
• Uphold the company mission statement and conduct yourself at all times in a respectful and business-like manner. Be a positive role model for all staff and interact with colleagues in a collaborative way
• Assist in set up and maintenance of laboratory and EMS system
• Execute other duties as may be required

Qualifications:

• Sc, post-secondary diploma in scientific, healthcare or pharmaceutical field, or equivalent.
• Minimum 2 years experience in a clinical research environment preferably including BE and Ph 1– IV studies, EEC is desirable
• 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
• Good trouble-shooting and decision making skills, able to escalate response to situations when relevant
• Proven solid project planning/coordination/management skills

Required experience:

• Clinical Trials: 1 year