- Identify the clients' expectations/objectives/deliverables
- Identify the performance metrics
- Identify the roles and responsibilities all parties involved from the sponsor, the external vendors and Scimega, as well as the communication process within parties.
- Set up "Kick-off meetings" with our clients
- Assist with the conduct of feasibility studies
- Recruit investigators in accordance with the feasibility studies
- Organize pre-study visits
- Organize and coordinate start-up activities at the different sites including negotiation of site's clinical trial agreement and clinical grants
- Prepare/review training material for the study initiation visits
- Organize study initiation visits
- Develop and implement internal processes for the conduct of clinical trials, including, but not limited to, the monitoring plan, communication plan, tracking systems, study tools and safety plan
- Host/Attend conference calls and periodic meetings with clients and prepare minutes (as applicable)
- Manage Trial Master File (as applicable)
- Prepare and distribute progress reports to clients in respect with Scimega's contractual obligations
- Prepare and distribute Scimega project review at every 2 months to Director Clinical and Scientific Affairs
- Interact/Collaborate with different vendors (as applicable)
- Write newsletters and have them approved by our clients (as applicable)
- Identify solutions to problems and take the necessary actions to avoid/minimize them and document the action in the Scimega project review
- Identify clients' needs and change in the scope of work and communicate the information to the Director Clinical and Scientific Affairs and document in Scimega project review
- Clearly communicate our client's expectations, objectives and deliverables (performance measures) to the CRAs
- Plan and organize CRA training on the specifics of clinical trials and our clients' needs. Ensure that all CRAs are adequately trained at all phases of the project.
- Ensure that all trainings are documented with a training log and are in the Scimega training binder.
- Provide initial study-specific training to new CRAs
- Schedule regular meetings and conference calls with the CRAs to discuss the progress of each trial and prepare the agenda and minutes.
- Discuss individually and regularly with each CRA to go over their performance measures
- Perform QC visit /Accompany CRAs during site visits on a regular basis
- Review monitoring reports and follow-up letters
- Support the CRAs (i.e. provide clarifications and answer questions, as applicable) and help them gain autonomy in their work and be proactive in their daily activities
- Review and approve CRAs timesheets
- Education: Bachelor's Degree in a Health Science field or Registered nurse. A master degree would be an asset
- Experience: Minimum 3 years experience as a CRA or pertinent experience in clinical trial management
- Other requirements/knowledge: Excellent knowledge in the field of oncology, very good knowledge of the Good Clinical Practices and regulatory environment
- Languages spoken and written: French and English if based in the province of Quebec. English if based in any other Canadian province.
- Ability to travel
- Excellent interpersonal skills
- Strong organizational skills and ability to handle competing priorities
- Strong communication (written and verbal) and presentation skills
- Ability to identify and solve problems
- Creativity
- Integrity/Honesty/Ethical behavior
- Passionate about our field of expertise
- Accountability
- Leadership
- Ability to supervise employees and manage their performance
- Flexibility
- Autonomy
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Oncology Clinical Research Associate - Laval, Canada - Scimega
Description
ROLE
Under the direction of the Director, Clinical and Scientific Affairs, the CTL is responsible for execution of clinical trials, from the site selection, start-up and enrollment phases up to the study closure, in compliance with the industry standards such as Scimega SOPs, ICH-GCP, FDA & Health Canada regulations, and in accordance with our client's expectations. The CTL is also responsible for customer relationships maintenance, and CRAs supervision.
ACTIVITIES / RESPONSIBILITIES
Site selection and Study start-ups
Study management and maintenance of client relationships
Supervision of our CRAs
REQUIREMENTS
Tangibles (qualifications)
Intangibles (skills and attitudes)
