Clinical Research Associate
1 week ago
We are seeking a highly skilled Clinical Research Associate to join our team at Scimega. As a Clinical Research Associate, you will be responsible for the execution of clinical trials, from site selection to study closure, in compliance with industry standards and client expectations.
Key Responsibilities- Site Selection and Study Start-ups
- Identify client expectations, objectives, and deliverables
- Develop and implement internal processes for clinical trial management
- Coordinate start-up activities at study sites, including negotiation of clinical trial agreements and grants
- Prepare and review training materials for study initiation visits
- Organize study initiation visits
- Study Management and Client Relationship Maintenance
- Develop and implement internal processes for clinical trial management, including monitoring plans, communication plans, and tracking systems
- Host and attend conference calls and meetings with clients, and prepare minutes
- Manage Trial Master Files and prepare progress reports for clients
- Identify solutions to problems and take necessary actions to avoid/minimize them
- Supervision of CRAs
- Communicate client expectations, objectives, and deliverables to CRAs
- Plan and organize CRA training on clinical trials and client needs
- Provide initial study-specific training to new CRAs
- Schedule regular meetings and conference calls with CRAs to discuss trial progress
- Tangibles (Qualifications)
- Education: Bachelor's Degree in a Health Science field or Registered Nurse
- Experience: Minimum 3 years experience as a CRA or pertinent experience in clinical trial management
- Knowledge: Excellent knowledge of oncology, Good Clinical Practices, and regulatory environment
- Languages: French and English (if based in Quebec), English (if based in other Canadian provinces)
- Intangibles (Skills and Attitudes)
- Excellent interpersonal skills
- Strong organizational skills and ability to handle competing priorities
- Strong communication and presentation skills
- Ability to identify and solve problems
- Creativity
- Integrity, honesty, and ethical behavior
- Passion for the field of expertise
- Accountability
- Leadership
- Ability to supervise employees and manage their performance
- Flexibility
- Autonomy
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