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Clinical Research Associate

vor 2 Monaten


Köln, Nordrhein-Westfalen, Deutschland Allucent Vollzeit
About the Role

We are seeking a highly skilled and experienced Senior Clinical Research Associate to join our team at Allucent. As a key member of our clinical operations team, you will play a critical role in ensuring the successful execution of clinical trials.

Key Responsibilities
  • Independently monitor and control investigational sites to ensure compliance with study protocols and regulatory requirements.
  • Proactively identify and resolve site-related issues to prevent delays and ensure study progress.
  • Collaborate with cross-functional teams to develop and implement study plans, including site initiation, monitoring, and closure visits.
  • Ensure accurate and timely data collection and reporting, including site visit reports and telephone contact reports.
  • Maintain and update clinical trial management systems (CTMS) to ensure compliance with study-specific directives.
  • Act as a liaison between the project team and site staff to ensure effective communication and issue resolution.
  • Participate in the start-up process, including preparing informed consent forms, developing study documents, and site contract management.
  • Identify potential logistical and practical problems and develop solutions to mitigate risks.
  • Ensure the continuous maintenance of the Trial Master File and Investigator Site File.
  • Assist the Project Manager and Clinical Team Leader with generation of study-specific forms and follow-up with teams to ensure timely completion and submission.
  • Work with the Project Manager, Clinical Team Leader, and Study Start-Up team members to ensure authorization of regulatory documents and site contracts.
  • Attend Investigator Meetings and study-specific training meetings to ensure effective communication and issue resolution.
  • Translate, coordinate translations, or review completed translations of essential documents as required.
  • Participate in feasibility and site identification activities, including contacting local opinion leaders, medical consultants, or specified investigators.
  • Identify documentation required for review by Regulatory Authorities and Ethical Committees, and prepare Regulatory and Ethics Committee submissions.
  • Prepare and attend Assessment Visits 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.
  • Assist the Project Team with day-to-day management of critical studies, including attendance at team meetings.
  • Provide secondary in-house review of CRFs as required.
  • Support site staff in preparation for study-related site audits and inspections.
  • Report Quality Issues and support the root cause analysis, writing of, and resolution of Corrective and Preventative Actions.
Requirements
  • At least 5 years of clinical monitoring experience and/or relevant clinical trial experience.
  • Relevant life science degree/healthcare/nursing background and/or related degree.
  • Sound knowledge of medical terminology and clinical monitoring process.
  • Ability to travel for up to 8 days on site per month, depending on project needs.
  • 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.
  • Attention to detail.
  • Ability to manage multiple projects.
  • Ability to work in a fast-paced, challenging environment of a growing company.
  • In-depth therapeutic and protocol knowledge.
  • Ability to work independently and effectively prioritize tasks, establish, and maintain strong working relationships with co-workers, managers, investigators, site personnel, and clients.
  • Demonstrated ability to manage multiple projects.
  • Proficiency with various computer applications such as Word, Excel, and PowerPoint required.
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.