Clinical Research Associate, French/German Speaking
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Job Description
Clinical Research Associate managing clinical studies at Insulet Corporation, supporting oversight of clinical activities and ensuring compliance with industry standards.
Responsibilities:
- Collaborate with team members in the evaluation and establishment of clinical study sites by performing site qualification visits to ensure applicability of sites for planned study.
- Collaborate with Senior Clinical Research Associate to create source documentation/CRFs in alignment with protocol requirements.
- Create consent and assent templates specific to the needs of the planned study.
- Collaborate with sites and internal stakeholders to align and implement site specific language for each consent/assent.
- Train site staff on protocol requirements, source documentation, and case report form completion.
- Serve as the primary liaison with Institutional Review Board (IRB) in the preparation and submission of all study related documentation including but not limited to the study protocol, consent/assent, user guides, training presentations, Curriculum Vitaes (CVs), licenses, and study amendments.
- Conduct regular monitoring visits to ensure study protocol compliance, primary data collection is recorded properly, and appropriate reporting is being conducted.
- Coordinate project meetings.
- Participate in the creation and review of clinical study reports for regulatory submission ensuring alignment of all the critical report elements such as adverse events, device deficiencies, etc.
- Participate in team meetings and track action items.
- Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.
Requirements:
- B.S. or B.A. and/or an equivalent combination of education or experience
- CRA certification preferred
- Fluent in English and French or German
- Available to travel on short notice and independently manage travel schedules
- Direct experience in participating in the execution of clinical research studies.
- Must have analytical skill, be detail oriented and have good interpersonal skills.
- Knowledge of agency guidelines and requirements.
Benefits:
- Flexible working hours
- Professional development opportunities
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