Clinical Research Associate monitoring sites, regulatory submissions, and trial documents for Emerald Clinical Trials. Supporting global clinical research across renal, cardiometabolic, and oncology therapies.
About the role
- Site Activation Specialist supporting clinical trial start-up, regulatory submissions, and site activation for Syneos Health. Coordinating country-level quality, compliance, feasibility, and investigator contract activities.
Responsibilities
- Responsible for country-level quality deliverables and compliance with project requirements and applicable country rules
- Track submission and approval milestones in the SSU tracking system and investigate or escalate timeline delays
- Monitor basic project financial aspects and contracted hours/tasks
- Review and comply with SOPs and Work Instructions and maintain training records and timesheet compliance
- Support quality improvement across Site Start-Up components, including submissions, essential document collection, and communication with Competent Authorities and Ethics Committees
- Ensure relevant documents are submitted to the Trial Master File
- Prepare and submit Central and Local Ethics Committee applications, Regulatory Authority applications, and other local regulatory or hospital approval submissions
- Prepare ongoing submissions, amendments, periodic notifications, and safety notifications as required
- Liaise between investigational sites and functional leads and oversee the end-to-end site activation process
- Provide country-level regulatory intelligence and support data protection guidance
- Provide input to local SOPs, Work Instructions, and internal training materials
- Support Ethics Committee or Competent Authority issue resolution
- Support site selection and feasibility activities
- May support investigator contract and budget negotiation, contract preparation, quality control, execution, archival, and metadata capture
Requirements
- Bachelor’s Degree
- Detailed understanding of clinical trial process across Phases II-IV and ICH GCP
- Ability to understand clinical protocols and associated study specifications
- Detailed understanding of clinical trial start-up processes
- Ability to manage external vendors to contract effectively
- Strong organizational skills with ability to handle multiple tasks effectively
- Strong written and verbal communication and interpersonal skills
- Ability to manage multiple project budgets with increased complexity and value
- Quality-driven in all managed activities
- Good negotiating skills
- Good problem-solving skills
- Demonstrated ability to work independently as well as part of a team
- French speaker
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations when appropriate
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Report this job
Found something wrong with the page? Please let us know by submitting a report below.
Local media buying specialist planning and negotiating French - content media campaigns for CBC/Radio - Canada. Managing partners, budgets, ad delivery, contracts, and performance reporting.
Freelance French fact - checking annotator evaluating response accuracy and misinformation for e2f's language - data projects. Applying structured guidelines remotely with flexible hours.
French - speaking Clinical Independent Rater reviewing psychiatric assessments and guiding raters. Supporting IQVIA’s clinical research trials through standardized scoring and data quality.
Volga Partners recruiting multilingual participants for paid English voice - recording research. Completing short English prompts remotely across diverse language backgrounds, accents, generations, and devices.
French (Canadian) Linguist delivering transcreation for global clients in the Apparel industry. Responsible for creative copy that aligns with brand messaging and tone.
Shape Canadian French AI language understanding through review, rewriting, and creation tasks. Join a global community at Welo Data contributing to AI system training.
Audio Contributor assisting in AI voice technology by recording scripted prompts in French. Requires clear reading and adherence to guidelines for consistency and clarity.
Trainer reviewing questions and images for AI data annotation project. Providing accurate answers based on observations to support AI systems development.
Rater evaluating personalized search and location recommendations for AI Services. Requires critical thinking about usefulness and context of digital experiences in Canada.