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
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
Study management and maintenance of client relationships
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
Supervision of our CRAs
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
Intangibles (skills and attitudes)
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
Integrity / Honesty / Ethical behavior
Passionate about our field of expertise
Ability to supervise employees and manage their performance