Clinical Research Associate II

5 dagen geleden

Amsterdam, Noord-Holland, Nederland Allucent Voltijd
About the Role

We are seeking a highly skilled Clinical Research Associate II to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for monitoring and managing clinical trials to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines.

Key Responsibilities
  • Conduct site visits to monitor and manage clinical trials, ensuring adherence to protocol, SOPs, and regulatory requirements.
  • Prepare and submit quality site visit reports and contact reports.
  • Manage and maintain clinical trial management systems (CTMS) in compliance with SOPs and study-specific directives.
  • Act as a document owner for collected documents and conduct co-monitoring as needed.
  • Provide functional assistance to project team members with administrative, logistical, and practical issues.
  • Liaise with project team members and sponsors to track study progress and milestones.
  • Track and supervise collection of ongoing study data for regular project status reporting.
  • 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.
  • Represent Allucent in the global medical research community, develop and maintain collaborative relationships with investigational sites and sponsor company personnel.
  • Identify potential logistical/practical problems and propose solutions/contingency plans with timeframes for resolution.
  • Supervise generation of electronic tracking systems and logs to produce status updates, progress reports, and general management of clinical deliverables when needed.
  • May process and track payments to Institutional Review Boards (IRB), Ethics Committees (EC), Regulatory Authorities, Investigators, and/or vendors, including timely notification to the finance department as applicable.
  • May participate in meetings with clients.
  • May support project manager/CTL and project functional leads in project oversight and management.
  • 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 Corrective and Preventative Actions.
Requirements
  • At least two years of 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 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.
  • Effective clinical monitoring skills (all kinds of visits mastered).
  • 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.
  • Ability to proactively identify and resolve issues in a timely manner.
  • Effective oral and written and presentation communication skills, with the ability to communicate effectively with medical personnel.
  • Effective organizational and time management skills.
  • Ability to manage multiple projects and strong attention to detail.
  • Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel, and clients.
  • Ability to meet project requirements.
  • Proven flexibility and adaptability.
  • Ability to work in a team or independently and to effectively prioritize tasks.
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.

Disclaimer: Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our locations.

Disclaimer: The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.

Disclaimer: #LI-BL1

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