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Lead CRA - Spain/Portugal Nr ref.: /JOBS.pl Salary: 45.00-60.00 Euro . EUR (Hourly)   I am exclusively representing one of my US Biotech clients and searching for a Lead Regional CRA for to help monitor and co-monitor Oncology trials across Spain and Portugal. The successful candidate will take on the following responsibilities and have the following experience and qualifications: Study Start up: feasibility, site selection, document development and review, etc Independently conducts and co-monitors all types of monitor visits including: qualifying site assessments, initiation, interim and closeout when necessary. Build partnership with CRO CRAs and perform oversight accompanied visits: Review previous monitoring visit reports and follow-up letters, meet with CRO CRAs prior to visit to discuss visit plan, observed CRO CRA's visit conduct, professionalism, comprehension of the study protocol(s), protocol-related procedures, and visit findings during conduct of monitoring visit. Conduct review of site study subjects executed/signed ICFs, source documents review and comparison to CRF data, CRF data corrections, storage review, site facility, study supplies review, regulatory binder review, and ensure SAE reporting according to project specifications. Document any visit findings observed, review visit findings with the CRO CRA, and observe CRO CRA meeting with PI and site staff, providing assistance/feedback when necessary. Following the completion of each accompanied visit, reviewed CRO CRA draft visit reports and follow-up letters for completeness and accuracy, providing feedback/comments when necessary, and complete sponsor oversight accompanied visit report, and escalate any findings. Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to the CTM Document and communicate study site progress and issues/concerns to the project team in a timely manner. Address study site issues/concerns with the investigator and independently offer resolution strategies, documenting follow-up activities and outcomes Participate in weekly project team meetings and various in-house initiatives as needed Requires 60% Travel BS/BA degree or equivalent (background in life sciences preferred) 5+ years of field monitoring and management within the pharmaceutical industry performing pre-study visits, initiation, interim and close out visits Minimum of 3 years of recent Oncology Experience (ovarian preferred) Must have Lead CRA/Oversight Experience Experience mentoring CRAs/Junior CRAs preferred Experience with EDC systems Strong attention to detail Working knowledge of FDA regulations and ICH/GCP guidelines Proven ability to demonstrate strong decision making and problem solving skills Excellent verbal and written communication skills as well as interpersonal and organisational skills Attention to detail; ability to prioritise and handle multiple tasks effectively Ability to work within established time lines, in a fast paced environment Ability to work both independently as well as in a team environment For a confidential discussion about this rare opportunity, please contact Phil Rose or email your CV to (see below) Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice. By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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