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Administracja biurowa » Pracownik biurowy

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Freelance / Contract CRA - Bulgaria Nr ref.: /JOBS.pl We're looking for a talented and energetic Freelance Clinical Research Associate to join our team! This role will be based in our office in Sofia, Bulgaria. You'll be accountable for: Delivering high-quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan timelines. Scheduling site visits for monitoring as required by protocol monitoring visit windows. Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites Monitoring data - remotely, on site, and via other approved modes - with a focus on data integrity and patient safety, in accordance with specific country regulations. Planning day-to-day activities for study monitoring and setting priorities by site. Preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites. Maintaining the project tracking system of subjects and site information. Participating in Investigators' Meetings as assigned by Project Managers. You'll need this to be considered: Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required Previous on-site monitoring experience is essential Certified according to the Ministerial Decree Fluent English and Bulgarian (verbal and written) Knowledge of ICH / GCP regulations Excellent team player, collaborative and able to enable an effective team Excellent organizational and time-management skills, able to meet deadlines Self-starter with lots of common sense and able to act on own initiative Maintains a positive, results orientated work environment Travel: 70-85% Valid driver's license, passport as required We're looking for a talented and energetic Freelance Clinical Research Associate to join our team! This is an exciting opportunity to join the team in our office in Sofia, Bulgaria Description Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases. We're looking for a talented and energetic Freelance Clinical Research Associate to join our team! This role will be based in our office in Sofia, Bulgaria. You'll be accountable for: Delivering high-quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan timelines. Scheduling site visits for monitoring as required by protocol monitoring visit windows. Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites Monitoring data - remotely, on site, and via other approved modes - with a focus on data integrity and patient safety, in accordance with specific country regulations. Planning day-to-day activities for study monitoring and setting priorities by site. Preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites. Maintaining the project tracking system of subjects and site information. Participating in Investigators' Meetings as assigned by Project Managers. You'll need this to be considered: Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required Previous on-site monitoring experience is essential Certified according to the Ministerial Decree Fluent English and Bulgarian (verbal and written) Knowledge of ICH / GCP regulations Excellent team player, collaborative and able to enable an effective team Excellent organizational and time-management skills, able to meet deadlines Self-starter with lots of common sense and able to act on own initiative Maintains a positive, results orientated work environment Travel: 70-85% Valid driver's license, passport as required Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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