Allucent is hiring a
Sr. Clinical Research Associate in Spain

Summary

The job description is for a Senior Clinical Research Associate (Sr. CRA) at Allucent™. The role involves managing clinical studies, ensuring compliance with regulations, providing functional assistance to the project team, and more. Key requirements include at least 5 years of experience, strong therapeutic background, ability to travel up to 8 days per month, excellent communication skills, organizational abilities, team player skills, knowledge of regulatory submission and reporting requirements, understanding of the drug development process, and maturity in managing people/project issues.

Responsibilities

• Independently control and monitor investigational sites
• Provide functional assistance to the project team members
• Track and supervise collection of ongoing study data
• Assist the Clinical Operations Manager in conducting feasibility assessment for potential studies
• Govern minimum quality standards for trial monitoring activities
• Ensure adequate tracking is in place for all activities and reports formatted as required for submission within agreed timelines
• Monitor activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols
• Collect and review regulatory documents as required
• Prepare site visit and telephone reports
• Responsible for multiple projects and must work both independently and in a team environment
• May participate in the study development and start-up process
• Resolve site issues and determine status for IP shipment
• Work with Project Manager (PM), Clinical Team Leader (CTL) and/or Lead Clinical Research Associate (LCRA), regulatory team members or Sponsor to secure authorization of regulatory documents and contracts
• May translate, coordinate translations or review completed translations of critical documents
• Participate in feasibility and/or site identification activities
• Assist the Project Team with the day-to-day management of clinical studies as required
• Monitoring Visit Report (MVR) review, management, resolution and escalation as required
• Train, mentor and/or supervise junior staff
• May be assigned as LCRA to a regional or global study
• May be assigned as a reviewer of essential documents (GLP) as a 2nd line or Independent Reviewer (IR)
• Conducts project co-monitoring, assessment visits and team training
• Site contact for protocol clarifications and subject enrolment if CRA unavailable
• Participate in the development of study newsletters communication as required
• Assist with the development of project-specific training materials for team
• Liaise with Business Development and make presentations to potential clients as required
• May be required to manage the preparation of local clinical trial applications (for regulatory submissions for new drugs, biologics, or devices)