Allucent is hiring a
Clinical Research Associate, Remote - Mexico

Summary

The job description is for a Sr. Clinical Research Associate I position at Allucent™, a company that helps small-medium biopharmaceutical companies navigate clinical trials. The role involves monitoring and managing clinical studies, ensuring compliance with protocols and regulations, and maintaining quality standards. The position is remote with travel.

Requirements

• At least five years clinical monitoring experience and/or relevant clinical trial experience
• Relevant life science degree / medical / nursing background, or combination of education and experience
• Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures
• Strong written and verbal communication skills including good command of English and local language
• Representative, outgoing and client focused
• Ability to work in a fast-paced challenging environment of a growing company
• Administrative excellence
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required

Responsibilities

• Governs highest possible quality standards for trial monitoring activities
• Conducts all study tasks in compliance with quality, while preserving efficiency and in alignment to the scope of services and budgeted hours
• Monitors activities at clinical study sites to assure adherence to protocol, Monitoring Plan, ICH, GCP, SOPs, and applicable regulations and guidelines
• Performs efficient site management in line with study budget
• Prepares and submits quality Site Visits Reports and Contact reports
• Maintains and updates CTMS in compliance with SOPs and study-specific directives
• Acts as Document Owner for collected documents
• Conducts co-monitoring as needed
• Provides functional assistance to the project team members with administrative, logistical, and practical issues
• Liaises with project team members and Sponsor to track study progress and milestones
• Tracks and supervises collection of ongoing study data for purpose of regular project status reporting within agreed timelines
• May review essential documents (GLP) as a 2nd line or Independent Reviewer (IR)
• May participate in organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project specific CRA training
• May perform assessment visits
• Represents Allucent in the global medical research community, develop and maintain collaborative relationships with investigational sites and sponsor company personnel
• Identifies potential logistical/practical problems and propose solutions / contingency plans, with timeframes for resolution
• Acts as the lead contact in case several CRAs involved for a same study in same country
• Supervises generation of electronic tracking systems and logs to produce status updates, progress reports and general management of the clinical deliverables when needed
• May process and track payments to the Institutional Review Boards (IRB), Ethics Committees (EC), Regulatory Authorities, Investigators and /or vendors including timely notification to finance department, as applicable
• May participate in meetings with clients
• May support project manager/CTL and project functional leads in the project oversight and management
• Supports site staff in preparation for study related site audits and inspections
• Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions

Preferred Qualifications

• Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology
• In-depth knowledge of clinical trials and the critical elements for success in clinical trials
• Excellent understanding of the drug development process

Benefits

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms