Opening: Immediate, Permanent Fulltime
Company Overview:
The Canadian Heart Research Centre is a federally incorporated not-for-profit academic research organization. We deliver integrated Continuing Medical Education programs that partner with pharmaceutical companies to deliver measurable results through clinical research initiatives across the cardiovascular continuum. Our educational programs provide relevant, evidence based and recent information for the professional development of physicians.
Position Overview:
We are currently seeking a Senior Project Leader for our North York office in our busy Clinical Trials Unit Department Working in the Clinical Research Unit with Principal Investigators, Clinical Research Manager, Reg/Audit Coordinator, Clinical Research Coordinators and administrative support staff, this position reports to the Director Clinical Trials Operations. The applicant should be self-motivated and able to take initiative in a dynamic and fast-paced environment. Candidates are expected to have strong communication skills, both written and verbal, relevant planning experience and willingness to travel.
Job Description:
- Monitor single/multi-centre trials, phase 2 – 4 studies as assigned by Manager, Clinical Monitoring ensuring the trial is run according to ICH-GCP, applicable Regulatory requirements, study protocol and Sponsor and/or company SOPs
- Conduct site qualifying visits to assess the suitability of investigator and site by ensuring the investigator has the staff, time, patient population and facility to complete the study successfully according to GCP and Regulatory requirements
- Conduct study initiation visits to review all study procedures with the investigative team and to ensure expectations of study is understood
- Conduct routine monitoring for single/multi-centre trials, to verify rights, safety and well being of patients are protected, ensure accuracy of study data and that the study is conducted according to the protocol, GCP and Regulatory requirements
- Conduct study close-out visits to ensure all essential documents are appropriately filed, to ensure investigator understands ongoing responsibilities Ensure that all visits are conducted according to Health Canada / FDA regulations and ICH guidelines, company or client Standard Operating Procedures
- Prepare protocol specific training and regular updates to CRAs and other staff, as required
- Assist Clinical Trials Specialist with the collection of regulatory documents required for drug shipment clearance, as required
- Review regulatory documents as required during routine monitoring and audits, ensuring investigator files are accurate, current and identical to Trial Master File
- Communicate with the study site personnel and study team members as appropriate and maintain a good rapport with each
- Provide Manager with monitoring reports of activities and elevate site or study issues
- Track all time and expenses and submit in a timely manner
- Work with the Quality Assurance group in the development/revision and implementation of Standard Operating Procedures as required.
- Ensure compliance with appropriate SOP’s GCP and ICH guidelines.
- Ensure personal resume (CV) is updated annually as required.
- Required to travel (Canada and US) including evenings and weekends (up to 4 days per week if required)
- Other related duties as assigned
Education, Qualifications and/or Experience:
- B.Sc. in health sciences or equivalent , Completion of an approved Clinical Research Program is preferred
· SOCRA certification is preferred in clinical research and a related regulatory reporting requirement is an asset.
· Data management experience is preferred
· 3-5 years experience in monitoring multi-centre clinical trials within the pharmaceutical industry or equivalent experience
· Excellent organizational abilities with great strength in managing details
· Ability to multi-task and handle many projects at the same time
· Must work well independently and under pressure with minimal support
· Excellent customer service skills, team player, high energy, great attitude
· Proficiency in MS Word, Excel, PowerPoint and Outlook
· Bilingual French and English - written and oral skills as asset
Working Conditions and Environment:
- This role at times may require approximately 60 - 80% travelling
- This role will require the flexibility to work in an environment that is constantly changing and work with a variety of different individuals
Thank you for your interest in the Canadian Heart Research Centre. Please email your application to hr@chrc.net . While we appreciate the interest of all applicants, only those candidates considered will be contacted. Please note, resumes will be kept on file for future consideration for a period of three months.