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Informed Consent and Study Start-Up Specialist Job

Eingestellt von Yoh

Gesuchte Skills: Client

Projektbeschreibung

INFORMED CONSENT AND STUDY START-UP SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in East Hanover, NJ.

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

  • Einsatzort:

    East Hanover, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung

  • Skills:

    client

Yoh