Overview

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

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

or proceed with Standard Application Form.

Employment Type: Part Time
Location: Mississauga, ON, CA
Posted on: 2015-08-01
Posted by: