Beschreibung
Wir, die Accessio IMS, suchen ab dem 22.03.2021 für unseren Kunden einen Freelancer Informed Consent Review Specialist (m/f/d) für ca. 3 Monate am Standort Raum Darmstadt & remote.The position will be all Remote.
Your Role
The Informed Consent Review Specialist is accountable for:
- TMF reconciliation, Quality Check and Discrepancy Documentation
- Read and review Informed Consent Forms - ICF (globally) and
complete ICF Tracking / Attribute Log
- Ensure compliance and inspection readiness of Phase I-IV clinical trials
Who You Are
- Bachelor degree graduate (or equivalent) in life sciences (e.g.
biology, chemistry, pharmaceutics)
- Experienced in clinical research for at least 1-2 years as CTA; CRA
or study start-up specialist, preferably
- Extensively experienced in eTMF systems and Informed Consent
creation / review
- Very fluent (spoken and writing) in the English language;
knowledge of other language(s) would be a plus
- Knowledgeable in ICH-GCP regulation, other relevant guidance
documents (e.g. FDA, EMA) and requirements of Informed Consent
in major countries
- Experienced in related systems and databases such as CTMS; EDC
would be a plus
- Excellent in writing and verbal communication skills with high
attention to details
- Demonstrate analytical skills and critical thinking to resolve issues
in a variety of complex situations requiring new solutions
- Used to working in an international environment
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