Upsilon Global

Permanent CRA - Germany - Oncology

Ort
Germany (DE)
Gehalt
Competitive Salary
Veröffentlicht
Donnerstag, 17. Juni 2021
Ablaufdatum
Samstag, 17. Juli 2021
Ref.
CB
Stunden
Vollzeit
Vertragstyp
Festanstellung
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Upsilon Global are partnered with this small Dutch CRO who, specialise in Oncology, Rare diseases, and CAR-T, having recently won an award for their work within T Cells. After merging with a US based regulatory company in 2019 to create a global presence, this CRO are looking to cover a large majority of clinical operations, regulatory and biostatistics. In 2020 they continued to expand across all areas by acquiring a small biostatistics company, by doing so they help to standardise their high level of quality throughout all clinical processes.

With 30 years’ experience worldwide and having conducted over 500 trials, this CRO are currently operational in 25 countries and have a view to build their German entity. There are currently 25 people active within Germany, meaning that individual efforts are acknowledged and appreciated.

We are presenting an exciting opportunity to collaborate with this CRO in the position of a Clinical Research Associate II, working within Oncology.

Location: Germany

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 subject eligibility
  • 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
  • Qualifications:
  • Life science, healthcare, medicine and/or related degree
  • Minimum 1-2 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
  • This CV is subject to agreed terms and conditions. To engage with the profile or for more information contact
  • Upsilon Global on +44 (0)20 3875 9966 or info@upsilonglobal.com
  • 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 German 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
  • Proficiency with various computer applications such as Word, Excel, and
  • PowerPoint required
  • Strong organizational skills
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