Clinical Research Associate II
8 ore fa
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 regulatory requirements.
- 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.
- 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 ensure effective communication with the project team.
- Collaborate with the Centralized Monitoring Team to evaluate risk-based monitoring activities and ensure the quality of study conduct.
- Identify and mitigate potential logistical and practical problems to ensure the successful execution of studies.
- Ensure the continuous maintenance of the Trial Master File and Investigator Site File.
- Assist the Project Manager and Clinical Team Leader with the generation of study-specific forms and follow-up with the teams to ensure timely completion and submission.
- At least 2 years of experience in clinical research.
- Strong therapeutic background and knowledge of clinical trials.
- Ability to travel for up to 8 days per month, depending on project needs.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Strong organizational and problem-solving skills.
- Ability to define and meet project requirements.
- Comprehensive benefits package.
- Competitive salary.
- Departmental study/training budget for furthering professional development.
- Flexible working hours.
- Opportunity for remote/hybrid working.
- Leadership and mentoring opportunities.
- Participation in our Buddy Program.
- Internal growth opportunities and career progression.
- Financially rewarding internal employee referral program.
- Access to online soft-skills and technical training.
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