Clinical Research Associate II
vor 4 Wochen
At Allucent, we are dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials. We are seeking a Clinical Research Associate II to join our team.
Key Responsibilities:
- Monitor investigation sites to ensure compliance with SOPs, regulations, and Good Clinical Practice.
- Perform site visits, including selection, initiation, monitoring, and closure visits.
- Track and supervise collection of study data for 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 start-up process, including preparing Informed Consent forms, developing study documents, EC/CA submissions, and site contract management.
- Proactively prevent and mitigate issues, resolve site issues, and determine status for IP shipment.
- Act as main line of communication between project team and site staff.
- Collaborate with Centralized Monitoring Team to evaluate risk-based monitoring activities.
- Identify potential logistical/practical problems and support Project team to create solutions/contingency plans.
- Ensure continuous maintenance of Trial Master File and Investigator Site File.
- Assist Project Manager and Clinical Team Leader with generation of study-specific forms for completion by CRA and Investigators.
- Work with Project Manager, Clinical Team Leader, SSU team members, or sponsor 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/or site identification activities, including contacting local opinion leaders, medical consultants, or specified investigators.
- Identify documentation required for review by Regulatory Authorities and Ethical Committees, prepare Regulatory and Ethics Committee submissions, and ensure written approvals are obtained and distributed appropriately.
- Prepare and attend 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.
- Assist Project Team with day-to-day management of critical studies, 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.
- Report Quality Issues and support root cause analysis, writing of, and resolution of Corrective and Preventative Actions.
Requirements:
- At least three years clinical monitoring experience and/or relevant clinical trial 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.
- 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 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.
- 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.
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