Pharma Medica Research (PMRI) Inc. is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. If your career goals align with innovation and original thinking you will be the perfect candidate to be part of an inclusive, adaptable, and forward-thinking organization. Our reputation for delivering high quality research is outstanding.
At PMRI we are committed to making a difference in healthcare and people's lives. Come join our team! We are currently looking for a Clinical Research Associate to join our Scarborough Team!
The CRA (Clinical Research Associate) monitors clinical trials conducted at the Pharma Medica Research Inc. (PMRI) clinical facility and external clinical sites. This position reports to the Director, Project Management, Innovator Division and/or designate. This position is crucial in assuring that clinical trials conducted at PMRI clinical facility and external clinical sites are monitored effectively to ensure compliance
Good Clinical Practice (GCP), clinical trial protocol/amendments, SOPs and applicable regulatory requirements. Since the task of monitoring is delegated by the Sponsor, this position acts on behalf of the Sponsor to ensure clinical trials are effectively monitored. Failure to do so effectively will have a negative impact on PMRI's reputation as well as client and regulatory satisfaction.
Duties and ResponsibilitiesMonitor clinical trials conducted at the PMRI clinical facility and external clinical sites for compliance with Good Clinical Practice (GCP), clinical trial protocol/amendments, SOPs and applicable regulatory requirements. Ensure that the rights and well-being of subjects are protected.
Perform Site Initiation Visits (SIV), Pre-Study Monitoring, On-Study Monitoring, and monitoring Close-Out visits. Review clinical trial source documentation for accuracy, completeness and compliance with Good Clinical Practice (GCP), clinical trial protocol/amendments, SOPs and applicable regulatory requirements.
Verify transcription of source documentation to Case Report Forms (CRFs). Document each monitoring visit in a monitoring report; follow-up and review site corrective actions to ensure effective resolution.
Submit monitoring reports to the site and Sponsor. Ensure effective communication with the site and the Sponsor; ensure critical observations are immediately communicated to the site and Sponsor and effective resolution is obtained. Coordinate and host external Sponsor CRA on-site visits; ensure effective communication between the CRA and PMRI.Supervise new CRAs as needed.
Ability to travel
Other duties as required.Requirements:Bachelor of Sciences DegreeAdditional education and training in clinical research.Recognized certification in clinical research (ACRP or SoCRA) is an asset.2-4 years CRA working experience.Excellent knowledge of GCP.Excellent communication and interpersonal skills.Ability to work with minimum supervision.Detailed oriented.Excellent problem solving and organizational skills.We offer: Competitive compensation plan
Mentorship OpportunitiesA benefit plan that is fully paid for by PMRI, including healthcare, dentalcare, vision care, LTD, Life Insurance, AD\&D, along with a Health Spending and Wellness Spending Accounts and a voluntary RRSP Contribution PlanOpportunities for advancement and career progressionA generous Employee Milestones Awards ProgramCorporate Discounts ProgramLearning Support Programs Friendly atmosphere, culture of learning
Please note all applications must be eligible to work within Canada.PMRI is an Equal Opportunity Employer; promoting accessibility and inclusivity at work and offering accommodation for applicants as required and requested.We thank all applicants for their interest; however, only those selected to proceed in the interview process will be contacted.
