Informed Consent Review Specialist
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Location
Remote
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Sector:
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Job type:
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Contact:
Charlie Mills-Swanscott
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Contact email:
charliemills-swanscott@hotmail.co.uk
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Salary high:
0
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Salary low:
0
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Job ref:
CM1
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Published:
about 1 month ago
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Duration:
Initially 3 Months
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Expiry date:
2021-04-09
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Startdate:
ASAP
A leading life science company requires a Informed Consent Review Specialist to join their business, offering a fully remote opportunity (you can be based across Europe), the role is an inital 3 Months contract with potential for extension.
Responsibilities:
- As the Informed Consent review specialist you will be responsible for TMF reconciliation, Quality Check and Discrepancy Documentation
- As the Informed Consent Review specialist you will 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
Experience:
- Experienced in clinical research for at least 1-2 years as CTA; CRA or study start-up specialist, preferably
- Extensive experience in eTMF systems and Informed Consent creation / review
- Has clear Knowledge and experience 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
If you are interested in learning more about the role you can reach me via email @ c.mills-swanscott@hamlynwilliams.com or via telephone +44 203 545 1110
I look forward to hearing from you,
#LI-CM5