Senior Clinical Research Associate

Summary

Join Allucent™ as a Sr. Clinical Research Associate (Sr. CRA) and play a vital role in advancing life-changing therapies. This hybrid/remote position requires independent management and monitoring of investigational sites, ensuring compliance with protocols and regulations. Key responsibilities include site visits, data collection, report preparation, and communication with project teams and site staff. The ideal candidate possesses at least 5 years of clinical monitoring experience, a relevant life science degree, and strong communication and organizational skills. Allucent offers a comprehensive benefits package, including competitive salaries, professional development opportunities, flexible working hours, and remote work options.

Requirements

• At least 5 years clinical monitoring experience
• Relevant life science degree/health care/nursing background and/or related degree
• Sound knowledge of medical terminology and clinical monitoring process
• Strong communication in Local and English language in both written and verbal skills
• Strong interpersonal and organizational skills
• Ability to translate guidelines, rules and regulations in clear and usable recommendations
• Representative, outgoing and client focused
• Ability to work in a fast-paced challenging environment of a growing company
• Ability to travel for up to 8 days on site per month, depending on the project needs
• Attention to detail
• Ability to work independently and to effectively prioritize tasks, establish, and maintain strong working relationships with co-workers, managers, investigators, site personnel and clients
• Demonstrated ability to manage multiple projects
• Administrative excellence
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required

Responsibilities

• Govern quality standards for trial monitoring activities
• Perform Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adhere to project guidelines and Allucent SOPs for monitoring requirements
• Monitor activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols
• Track and supervise collection of ongoing study data for purpose of regular project status reporting
• Collect and review regulatory documents as required
• Prepare site visit reports and telephone contact reports
• Maintain and update CTMS in compliance with SOPs and study-specific directives
• Act as Document Owner for collected documents
• Participate in the start-up process including preparing Informed Consent forms, developing study documents, EC / CA submissions, and / or site contract management
• Aim to pro-actively prevent and / or mitigate issues. Resolve site issues, including site recruitment challenges, and determine status for IP shipment
• Act as the main line of communication between the project team and the site staff
• Work in collaboration with Allucent Centralized Monitoring Team to evaluate risk-based monitoring activities to facilitate oversight of the study conduct at the sites and prevent issues. Activities are related to but not limited to: Investigational Product supplies, non-IP study supplies, subject eligibility, protocol compliance, facilities, and PI oversight
• Identify potential logistical/practical problems and support Project team to create solutions / contingency plans, with timeframes for resolution
• Ensure the continuous maintenance of the Trial Master File and Investigator Site File
• Assist the Project Manager (PM) and Clinical Team Leader (CTL) with generation of study specific forms for completion by CRA and Investigators and follow up with the teams to ensure timely completion and submission
• Work with Project Manager (PM); Clinical Team Leader (CTL), SSU (Study Start Up) team members or sponsor to ensure authorization of regulatory documents and site contracts
• Attend Investigator Meetings (IM) to include organizing and presenting at investigator meetings. and study specific training meetings
• Translate, coordinate translations or review completed translations of the essential documents as required
• Participate in feasibility and/or site identification activities. Contact local opinion leaders, medical consultants or specified investigators and identify sites with the potential for participation. Follow feasibility procedures for documentation of feasibilities performed in collaboration with the Study Start Up Department
• Where applicable, identify the documentation required for review by Regulatory Authorities and Ethical Committees. Prepare Regulatory and Ethics Committee submissions working in conjunction with Study Start Up Department. Ensure written approvals are obtained and distributed appropriately prior to Site Initiation
• Prepare and attend an Assessment Visit with a more senior CRA, CTL or Clinical Research Manager as required
• Process interim and final payments to Investigators, including preliminary calculations, review and approval from Project Management, liaison with finance, logging trial expenditure, receipts, invoices, and income
• Assist the Project Team with the day-to-day management of critical studies as required, including attendance at team meetings
• Provide secondary in-house review of CRFs (if required)
• Support site staff in preparation for study related site audits and inspections
• Where applicable, report Quality Issues and support the root cause analysis, writing of and resolution of the Corrective and Preventative Actions
• Be assigned other tasks / activities / responsibilities related to the study execution in the country
• Support initiatives in the country, GCO, and / or CTO to contribute to improvements and quality
• Work both independently and in a team environment

Preferred Qualifications

• In-depth therapeutic and protocol knowledge
• Demonstrated ability to develop, organize and manage new skills and tasks and mentor colleagues

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