Senior CRA, German/French or German/Italian Speaking

This is a fully remote position, open to applicants in Switzerland.

📋 Description

• Conduct site qualification, site initiation, interim monitoring, site management, and close-out visits either on-site or remotely.

• Ensure adherence to regulatory standards, ICH-GCP/GPP guidelines, and protocol compliance.

• Assess site and staff performance, recommending site-specific actions as necessary.

• Address serious issues by escalating them and developing action plans.

• Confirm informed consent processes while safeguarding subject/patient confidentiality.

• Evaluate subject/patient safety, protocol deviations/violations, and pharmacovigilance concerns.

• Perform source document reviews to ensure clinical data accuracy and completeness.

• Resolve queries both remotely and on-site within the agreed timelines.

• Utilize hardware and software for clinical study data review and capture.

• Ensure compliance with electronic data capture standards.

• Oversee investigational product inventory, reconciliation, storage, security, and dispensing as necessary.

• Review Investigator Site Files and ensure they align with Trial Master Files.

• Document monitoring activities, entering observations, statuses, and action items into tracking systems.

• Aid in subject/patient recruitment, retention, and awareness initiatives.

• Manage site-level activities and communications to fulfill project goals, deliverables, and timelines.

• Collaborate with project site personnel to ensure that assigned sites and team members receive appropriate training and remain compliant.

• Prepare for and participate in Investigator Meetings, sponsor meetings, and clinical training sessions.

• Support audit readiness and follow-up actions post-audit.

• Provide training or mentorship to junior CRAs and conduct training/sign-off visits as designated.

• Undertake clinical operations lead tasks under supervision when assigned.

⛳️ Requirements

• A Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Significant monitoring experience in Switzerland.

• Proficient computer skills and a willingness to adopt new technologies.

• Exceptional communication, presentation, and interpersonal abilities.

• Basic level of critical thinking skills.

• Proficient in English.

• Native-level proficiency in German is essential.

• Ability to speak Italian or French is a plus.

• Willingness to manage required travel of up to 75% on a regular basis.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations when appropriate.