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Clinical Research Associate
4 months ago
These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.
**Responsibilities**:
- Perform initiation visits to train and instruct site staff on the study specific requirements
- Assist in site activation
- Perform Monitoring visits to:
- Verify that source data and study database are accurate, complete and maintained properly
- Verify protocol compliance, including safety reporting and drug handling
- Verify all study files are maintained and up to date
- Support site staff in preparation for study specific site audits and inspections
- Perform Close-out visits
- Perform Pre-study visits, if delegated by SSU
- Perform centralized and risk based monitoring activities
- Act as the main line of communication between the study PM/LCRA and the site staff
- Maintain study related trackers
- Prepare site visit reports
- Liaise with site staff to achieve patient recruitment targets
- Contribute to the development of study specific documents
- Support the study start-up team in preparation of the submission packages and collection of site documents, if delegated by SSU
- Actively support site management staff learning & development within the company
**Requirements**:
- Life science, healthcare, medicine and/or related degree
- Minimum 3-4 year of CRA experience
- Minimum 1-2 years of experience in drug development and/or clinical research
- Good knowledge of ICH-GCP, privacy legislation (GDPR and/or HIPPA), regulations (CTR/CTD and/or CFR), and applicable local regulatory requirements
- Good understanding of site management and monitoring
- The ability to perform site visits in an effective way and according to high quality standards
**Skills**:
- Strong written and verbal communication skills including good command of local and English language
- Representative, outgoing and client focused
- Ability to work in a fast-paced challenging environment of a growing company
- Administrative excellence with attention to detail and accuracy
- Strong organizational skills
**Benefits**
- Comprehensive benefits package
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Leadership and mentoring opportunities
- Internal growth opportunities and career progression
- Up to 8 days on-site monitoring per month (includes remote visits)
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms
To all recruitment agencies:_ Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes._
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