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About the Role

Pharma Medica Research is seeking a Study Coordinator I to join their clinic in Scarborough. This role involves planning and executing study activities, ensuring compliance with protocols and regulatory guidelines, and prioritizing subject safety.

Responsibilities

• Plan and supervise the timely execution of studies under the supervision of the Study Coordinator II.
• Generate a study summary based on the protocol.
• Ensure that regulatory documents like FDF, FDA 1572, QIU, ERB Letter of Approval, NOL, etc. are available prior to study check-in.
• Coordinate the ordering of study-specific materials to conduct clinical studies.
• Conduct pre-study protocol review meetings for the technical team.
• Ensure that the study schedule is prepared in compliance with the study requirements.
• Communicate with the Study Preparation Coordinator and the QC unit to ensure that appropriate CRFs are prepared prior to study check-in.
• Liaise with the Screening department to ensure that queries pending at check-in are addressed prior to drug administration.
• Ensure that the study drugs are received prior to study conduction.
• Communicate with the Principal Investigator to ensure that an Investigator is present to perform the necessary physical examination and monitoring procedures.
• Ensure that the ICF is provided to the subjects, answer any questions the subjects may have regarding the protocol and Informed Consent, and sign the Informed Consent forms.
• Supervise and when required, assist and/or perform all technical functions: phlebotomy, ECG, vital signs and other clinical tasks to generate data in compliance with protocol, SOPs and GCP requirements.
• Perform safety-related procedures as required (e.g. conducting vital signs, electrocardiograms, concomitant medication administration) and health monitoring.
• Assist or administer certain types of investigational products as required for the conduct of a clinical study under the supervision/order of the investigator.
• Ensure subject safety by timely documenting and following-up on Adverse Events.
• Ensure all study documentation is accurate, current, and complete according to study protocol, SOPs, GCP, and other regulatory guidelines.
• Coordinate with the Project Management department regarding study related issues and project deadlines.
• Assist in resolving conflicts among subjects and address subjects’ concerns.
• Generate client updates and forward to the Project Management department as required.
• Coordinate with the accounting department regarding study subjects’ compensation.
• Ensure the timely shipping of the clinical and analytical samples.
• Assist in performing final review of study documentation, ensuring accuracy according to protocol, SOPs and GCP, and other regulatory guidelines.
• Ensure timely completion of deviation forms as needed.
• Ensure timely receipt and review of post-study laboratory reports.
• Ensure timely completion of the study files according to project deadlines.
• Address queries and audit findings from QC and QA.
• Coordinate the transcription of raw data onto CRFs where necessary.
• Update the subjects’ files for outstanding follow-ups, subjects’ behavior issues, non-compliance, etc.
• Other duties as required.

Requirements

• Minimum B.Sc. degree with 1 year experience in conducting clinical trials or; M.Sc. degree with adequate knowledge of conducting clinical trials.
• Working knowledge of Phase I study Protocols and conduct.
• GCP training.
• Proficiency in computer usage and software applications.
• Excellent communication skills including excellent English verbal and written skills.
• Ability to communicate clearly and effectively with direct reports and other clinical staff.
• Excellent interpersonal skills.
• Ability to work both independently and as a team member.
• Flexibility with changes in working schedules/shifts.
• Exceptional organizational skills.
• Eligible to work within Canada.

Skills

• Phlebotomy
• ECG
• Vital signs
• Clinical tasks
• Health monitoring
• Investigational product administration
• Adverse event documentation
• Study documentation
• Client updates
• Subject compensation coordination
• Sample shipping
• Deviation form completion
• Laboratory report review
• Study file completion
• Query resolution
• Audit finding resolution
• Data transcription
• Subject file updates

Location

• Scarborough

Work Type

• Full service
• Full-time

Experience Level

• 1 year experience in conducting clinical trials

Education Level

• B.Sc. degree
• M.Sc. degree

Salary/Compensations

• $50,000 - $55,000/year

Benefits

• Competitive compensation plan
• Opportunities for advancement and career progression
• A generous Employee Milestones Awards Program
• Corporate Discounts Program
• Learning Support Programs
• Friendly atmosphere, culture of learning

About the Company

• Pharma Medica Research is a full service contract research organization specialized in conducting early phase clinical trails in healthy volunteers, special and patient populations.

Equal Opportunity

• PMRI is an Equal Opportunity Employer; promoting accessibility and inclusivity at work and offering accommodation for applicants as required and requested.