Study Coordinator - Clinical

Pharma Medica Research Inc.; Toronto; On-site; CAD 60,000 - 80,000; Full time

Benefits offered by this job

Competitive compensation

Fully paid healthcare plan

Career progression opportunities

Employee milestones awards

Corporate discounts

Friendly learning culture

Job summary

Pharma Medica Research (PMRI) Inc. is seeking a Clinical Study Coordinator for our Scarborough team to supervise planning and execution of clinical studies in a regulated environment.

You will ensure study documentation, prepare staff schedules, coordinate materials, and supervise clinical tasks to generate compliant data for analysis.

Qualifications

• Excellent communication skills including English verbal and written.
• Ability to communicate clearly with direct reports and other clinical staff.
• Excellent interpersonal and teamwork abilities.

Responsibilities

• Coordinate and supervise study activities to ensure protocol, SOPs and GCP compliance.
• Prepare study staff schedules and ensure study documentation is complete.
• Coordinate with Pharmacy to ensure study drugs are available in clinic.
• Supervise phlebotomy, ECG, vital signs and other clinical tasks as required.
• Monitor and document Adverse Events and report to QA as needed.

Skills

Communication

Verbal English

Written English

Teamwork

Organizational skills

Interpersonal skills

Education

B.Sc.

MSc (preferred)

Job description

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.

We are currently looking Clinical Study Coordinator to join our Scarborough team.

The Study Coordinator supervises the planning for clinical studies, supervises and/or performs all technical functions necessary to generate data in compliance with protocols, SOPs and GCP. Awareness of human safety factors. Ensures procedures are performed in a timely manner,. answering technical questions from technicians. Monitoring Adverse Events. Supervision and direction of technical staff on study in terms of performance of functions. This position reports to Manager, Clinical Operations and/or designate.

Duties and Responsibilities:

Responsibilities include but are not limited to:

• Ensure that the final protocol, signed regulatory documents, and NOLs are available prior to study conduction.
• Prepare the study-specific staff schedule.
• Ensure that the study CRFs are prepared, study supplies are available, and and the clinic is set up prior to study check-in.
• Coordinate with the Pharmacy department to ensure that the study drugs are available in the clinic prior to study check-in.
• Set up and conduct pre-study protocol review meetings of study activities for technical team.
• Coordinate ordering of study specific materials to conduct clinical studies.
• Supervise and/or perform all technical functions: phlebotomy, ECG, vital signs and other clinical tasks to generate data in compliance with protocol, SOP and GCP.
• Ensure subject safety by monitoring and documenting Adverse Events.
• Coordinate with the Accounting department regarding timely preparation of subjects’ compensation.
• Generate client update and forward to Client Services as required.
• Perform final review of study documentation, ensuring accuracy according to protocol, SOPs and GCP.
• Ensure all study documentation is accurate, current, and complete according to study protocol, SOPs, GCP, and regulatory guidelines.
• Coordinate transcription of raw data onto CRFs where necessary.
• Ensure the timely submission of study files to QA and Report Writers.
• Assist is resolving conflicts among subjects and address subjects concerns.
• Address queries and findings from QC unit and QA’s

Requirements:

• Minimum B.Sc. degree with 1 year Phase I clinic experience or 2 years related experience within a Phase I clinical center.
• Clinical Research Coordinator designation as per ACRP guidelines.
• MSc with experience preferred
• Excellent understanding of Phase I study protocols and conduct.
• Understanding of the value and necessity of training and SOP’s relating to study conduct GCP training
• 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.
• Exceptional organizational skills

We offer:

• Competitive compensation plan
• A 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 Plan
• Opportunities for advancement and career progression
• A generous Employee Milestones Awards Program
• Corporate Discounts Program
• 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.