Clinical Research Associate II
vor 1 Tag
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 successful execution of clinical trials.
Key Responsibilities:- Monitor and control investigation sites to ensure compliance with study protocols and regulations.
- Perform site initiation, monitoring, and closure visits to ensure data quality and integrity.
- Track and supervise the collection of study data to ensure timely and accurate reporting.
- Review and collect regulatory documents to ensure compliance with regulatory requirements.
- Prepare and submit site visit reports and telephone contact reports to stakeholders.
- Maintain and update the Clinical Trial Management System (CTMS) to ensure accurate and up-to-date information.
- Act as the primary point of contact for site staff and stakeholders to ensure effective communication and collaboration.
- Collaborate with the Centralized Monitoring Team to evaluate risk-based monitoring activities and ensure the quality of study conduct.
- Identify and mitigate potential issues and develop contingency plans to ensure study success.
- Ensure the maintenance of the Trial Master File and Investigator Site File to ensure compliance with regulatory requirements.
- Assist the Project Manager and Clinical Team Leader with the generation of study-specific forms and follow-up with stakeholders to ensure timely completion and submission.
- Work with the Project Manager, Clinical Team Leader, and Study Start-Up team members to ensure the authorization of regulatory documents and site contracts.
- Attend Investigator Meetings and study-specific training meetings to ensure effective communication and collaboration.
- Translate, coordinate translations, or review completed translations of essential documents as required.
- Participate in feasibility and site identification activities to identify potential sites for clinical trials.
- Identify and document the necessary regulatory approvals and ensure written approvals are obtained and distributed appropriately.
- 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 the Project Management team.
- Assist the Project Team with the 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.
- At least three years of clinical monitoring experience and/or relevant clinical trial experience.
- Relevant life science degree, healthcare, or nursing background, and/or related degree.
- Sound knowledge of medical terminology and clinical monitoring processes.
- Strong communication skills in English and local language, 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 of a growing company.
- 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 effectively prioritize tasks, establish, and maintain strong working relationships with coworkers, 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.
- Demonstrated ability to develop, organize, and manage new skills and tasks and mentor colleagues.
- 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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