Senior Clinical Research Associate in Oncology
vor 4 Wochen
**Linical** Co., Ltd. (‘Linical’) is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With approximately 900 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including Japan via its own offices and staff.
Linical’s European arm is headquartered in Frankfurt, Germany with a substantial presence in Paris and Madrid. Its geographic footprint facilitates a significant presence in the leading Western European markets, combined with well-established affiliate operations in key emerging markets in Central
- and Eastern Europe.
We offer individualized solutions that are tailored to the specific needs of our sponsors. We work as integrated teams functioning with maximum transparency throughout each study, making sure that the sponsor is kept up to date on all study parameters and progress. We are dedicated to the highest standards of quality, with a special focus on the therapeutic areas oncology, immunology and CNS, based on experience and expertise.
**Pharma Resourcing Solutions PRS**
Linical Pharma Resourcing Solutions (Linical PRS) has the experience and a clear understanding of the importance of our clients’ resourcing strategies. With the flexibility that this level of service requires, Linical is able to serve a full range of resourcing requirements as per our clients’ needs and expectations.
Linical PRS is supported by a strong and continuous recruitment activity, accompanied by qualified and highly experienced line management personnel as well as strong leadership oversight throughout the process. Thus, PRS can guarantee success and commitment to the project objectives of our clients.
We truly believe people are the real value of a company and we invest in their performance and their professional satisfaction.
For our further dynamic and successful company growth Linical Europe is seeking several well-experienced Clinical Research Associates.
Location: East Coast (home-based)
**Description of the tasks / routine work**:
- Ensure that the conduct of the study is in compliance with the currently approved study protocol/amendment(s), with ICH GCP, SOPs, and any applicable regulatory requirements in the assigned countries
- Conduct any kind of on-site monitoring visits (pre-study, initiation, routine monitoring, site closure)
- Review of and/or input to the study protocol, CRF and validation tools
- Preparation and/or review of Monitoring Guidelines, CRF Completion Guideline, patient information documents
- Preparation of submissions to Independent Ethics Committees (central and local) and to Competent Authorities
- Assisting of Investigator and Institution contracts, negotiating budgets and arranging site payments
- Query management in cooperation with the Clinical Data Management Team
- Assisting sites and the study team in managing contacts to external service providers such as central laboratories
- Participation in feasibility studies and Investigator selection
- Responsibility for Site Management.
- University degree in sciences or related fields; and experience and knowledge of clinical trials and regulations
- More than 3 years of experience as a CRA in Oncology
- At least 3 year experience in Clinical Monitoring in a pharmaceutical company or a CRO; Interventional experience in Phase I to III
- Sound knowledge of relevant guidelines (e.g. ICH GCP) and regulatory requirements
- Strong team player combining communication and organizational skills
- Travel availability
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