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Informed Consent and Study Start-Up Specialist Job
Eingestellt von Yoh
Gesuchte Skills: Client
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:
- Experience with HIPPA
- Experience starting up clinical trials
- Basic knowledge of consents
WHAT YOU'LL BE DOING:
- Review and negotiate the legal sections of the ICF pre-IRB submission, post IRB comments, confirms the language used in the approved ICF is acceptable and works on Amended ICFs.
- Collect regulatory documents for study start up procedures
- Work with the contracts group to facilitate the contract negotiation process.
- Interface with the clinical sites, their IRBs, their Document Specialist, the Contract manager, the Trial Leader and NPC legal (including Privacy Officer).
- Work with central IRBs to negotiate standard language in the ICF.
- Ensure study ICF-template for central IRB sites contain the approved pre-negotiated language
- Maintain electronic ICF repository of approved ICFs (scanning ICFs)
- Make necessary enhancements to the electronic repository of approved ICFs
- Work with privacy advisors for legal and HIPAA business decisions
- Develop new model ICF templates
WHAT YOU NEED TO BRING TO THE TABLE:
- Strong Communication Skills
- Pharmaceutical Experience
- Experience Starting Up Clinical Trials
- Experience working with the HIPAA Privacy Rule
- Strong Computer Skills, specifically Microsoft Word and Excel
BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:
- Experience negotiating ICF language with research centers and IRBs is highly preferred
WHAT ARE YOU WAITING FOR? APPLY NOW!
RECRUITER: Kara Lloyd
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. If you are an individual with a disability and you require an accommodation in the application process, please email.
J2W: SCIENTIFIC
MONJOBJ2WNECLIN
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
East Hanover, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung