Clinical Research Associate II
vor 1 Woche
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 ensuring the smooth execution of clinical trials, from site initiation to close-out.
Key Responsibilities- Monitor and control investigation sites to ensure compliance with study protocols and regulations.
- Perform site visits, including selection, initiation, monitoring, and closure visits, to ensure adherence to project guidelines and SOPs.
- Track and supervise the collection of ongoing study data for regular project status reporting.
- Review and collect regulatory documents as required.
- Prepare site visit reports and telephone contact reports.
- Maintain and update the Clinical Trial Management System (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, and site contract management.
- Proactively identify and mitigate issues, resolving site recruitment challenges and determining IP shipment status.
- Act as the main line of communication between the project team and site staff.
- Collaborate with the Centralized Monitoring Team to evaluate risk-based monitoring activities and facilitate oversight of study conduct at sites.
- Identify potential logistical and practical problems and support the project team in creating solutions and contingency plans.
- Ensure the continuous maintenance of the Trial Master File and Investigator Site File.
- Assist the Project Manager and Clinical Team Leader in generating study-specific forms for completion by CRAs and Investigators.
- 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, including organizing and presenting at investigator meetings and study-specific training meetings.
- Translate, coordinate translations, or review completed translations of essential documents as required.
- Participate in feasibility and site identification activities, contacting local opinion leaders, medical consultants, or specified investigators to identify potential sites.
- Identify documentation required for review by Regulatory Authorities and Ethical Committees, preparing submissions as needed.
- Prepare and attend Assessment Visits with a 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 root cause analysis, writing, and resolution of Corrective and Preventative Actions.
- At least three years of clinical monitoring experience and/or relevant clinical trial experience.
- Relevant life science degree, healthcare, or nursing background, or related degree.
- Sound knowledge of medical terminology and clinical monitoring processes.
- Strong communication skills in English, both written and verbal.
- Strong interpersonal and organizational skills.
- Ability to translate guidelines, rules, and regulations into clear and usable recommendations.
- Representative, outgoing, and client-focused.
- Ability to work in a fast-paced, challenging environment.
- In-depth therapeutic and protocol knowledge.
- Ability to travel for up to 8 days on site per month, depending on project needs.
- Attention to detail.
- Ability to work independently and prioritize tasks effectively.
- Demonstrated ability to manage multiple projects.
- Administrative excellence.
- Proficiency with various computer applications, including Word, Excel, and PowerPoint.
- 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.
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