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Business Analyst (Clinical Archiving) Job

Eingestellt von Yoh

Gesuchte Skills: Support, Client

Projektbeschreibung

BUSINESS ANALYST (CLINICAL ARCHIVING) needed for a contract opportunity with Yoh's client located in Danbury, CT.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Document Management
- Document Archiving
- Clinical Trial Master File

WHAT YOU'LL BE DOING:

- Accurately files complex, regulatory required, documents into Clinical Trial Master File (CTMF)
- Coordinates with scanning group to ensure accurate filing into CTMF
- Ensures all trial documentation is prepared, accurately filed and saved into CTMF
- Prepares and distributes Investigator Site File (ISF) to sites
- Prepare CTMF documents for inspection readiness
- Coordinate with Document Management System support staff to ensure appropriate data dictionaries are updated for new trials
- Liaise with trial personnel to follow-up on required documentation
- Reconciles trial documents throughout the trial in preparation for trial close-out
- Assists in Clinical Trial Report preparation by linking appendices with Document Management System
- Performs records retention for paper documentation

WHAT YOU NEED TO BRING TO THE TABLE:

- Minimum of three to five (3 - 5) years of administrative, customer service and/or relevant business experience.
- Requires a solid understanding of Clinical Trial master File requirements, Good Clinical Practices, and SOP's, document management system functionality and practices.
- Understanding of Regulatory Compliance and Record Retention policies.
- Familiar with ICH Good Clinical Practices, FDA Good Clinical Practices and other appropriate regulations

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Familiar with regulatory regulations concerning proper conduct and documentation of a clinical trial
- Ability to use document management and other office systems
- Understanding of Regulatory Compliance and Record Retention policies

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Chelsea Tevis

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

MONJOBJ2WNECLIN

Ref:

SFSF: REN

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh