Remote Clinical Research Associate II

Summary

Join Allucent as a Clinical Research Associate II (CRA II) and contribute to the efficient navigation of clinical trials for small-medium biopharmaceutical companies. As a key member of our A-team, you will independently monitor investigational sites, detect issues, and provide solutions to ensure clinical studies are performed according to protocol and in compliance with SOPs and regulations.

Requirements

• At least two 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
• Ability to travel for up to 8 days on site per month, depending on the project needs
• 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, including the tracking, collection, distribution and filing study documentation (CTMS, TMF)
• 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
• 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

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
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees