CRA II_Onco_with Portuguese
- Experience Level
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.
- 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.
As an ideal candidate you should have the following profile:
- university degree in sciences or related fields; and experience and knowledge of clinical trials and regulations,
- Advanced English and PORTUGUESE
- at least 2 years of experience in Clinical Monitoring in a pharmaceutical company or a CRO,
- sound knowledge of relevant guidelines (e.g. ICH GCP) and regulatory requirements,
- strong team player combining communication and organizational skills,
- Travel availability
- ONCOLOGY Experience