Join The Team
Scimega Oncology’s team of experts provide oncology clinical trial services to small and midsized biopharma companies involved in oncology clinical research programs, phases I – III
We are currently looking for individuals with a passion for Oncology Drug Development to join our team of oncology experts to oversee the conduct of novel trials in Canada. Our current clinical trial portfolio is composed of Immuno-oncology, Antibody-Drug Conjugates, Gene Therapy, Precision Prodrug-Delivery Technology, Radiopharmaceutical Imaging and novel targeted small molecules. If this is you, apply now!
We Are An Equal Opportunity Employer
We welcome you to send your C.V. to email@example.com. Please include a cover letter outlining relevant work experience, professional skills, and the position you seek. We appreciate your interest in Scimega Oncology, however only candidates selected for an interview will be contacted.
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
To apply for this position, please submit your resumé to:
Under the direction of CTL (Clinical Trial Leader) and in accordance with customer specifications/values and Scimega’s corporate standards, the clinical research associate has the primary responsibility for managing and advancing clinical trials in its respective sites, and ensuring that the rights and welfare of study subjects are always respected.
The CRA ensures the rights and welfare of study subjects are always respected; all site staff involved in the conduct of the clinical trial meets the study protocol, customer procedures, and applicable regulations; the integrity and quality of data collected.
- Bachelor’s Degree in a Health Science field or registered nurse
- Minimum 2 years experience as a CRA, preferably in the field of oncology. Excellent knowledge in the field of oncology, Good Clinical Practices.
- Must be passionate about Oncology Clinical Research. Excellent interpersonal skills. Strong organizational skills and creativity. Capable to develop a good level of autonomy and carry-on 360-degree site management responsibilities.
- Languages spoken and written: French and English (able to monitor source documents and interact with site personnel in both languages)
TO APPLY FOR THIS POSITION
Please submit your resume to:
Why Scimega ?
We are at the forefront of oncology clinical operations in Canada because we attract the best and the brightest in the business. We share a vision for extending people’s lives and enhancing their quality of life. We are dedicated to giving cancer patients greater access to cutting-edge oncology studies. Trusted, long-term relationships with sites have always been the cornerstone of our success. Our clients love working with us because we deliver on the promise of First Patient-In and strong enrolment, which allows them to meet their timeline objectives.
We believe in creating an inspiring work environment, where our people are recognized, supported and given the opportunity to grow. As a valued member of our team you will be contributing to making our world a better place.
Our Values ?
Here are some of the core values that support our mission and vision.
- Create Value
- Develop Talent
- Deliver Quality
- Act with Integrity & Respect
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