Clinical Project AssociateFladger Associates • San Mateo, California, United States

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Clinical Project Associate

Fladger Associates

About

Foster City, CA
Contract Duration: 6-24 months
Rate: Negotiable
Salary: NA $1.00
Responsibilities:

Excellent employment opportunity for a Clinical Project Associate in the Foster City, CA area.
Work under general supervision for routine tasks and with detailed instructions on new assignments.
Tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools.
Processes drug shipments, drug returns, and assists with in-house drug reconciliation.
Orders and maintains inventory of clinical supplies.
Orders and ships case report forms.
Assists with development of documents for site binders.
Assembles and prepares distribution of site binders.
Serves as CRA back up providing verbal and written communication with study personnel.
Under close supervision reviews and participates in the quality assurance of data or documents.
Arranges meeting logistics.
Drafts meeting agendas and assists in preparing meeting minutes.
May assist with monitoring visits under the direct supervision of senior staff.
Travel may be required.

Experience:

BA is a requirement
Excellent verbal and written communication skills and interpersonal skills are required.
Must be familiar with Word, PowerPoint, and Excel.
Knowledge of FDA and or EMEA Regulations, ICH Guidelines, GCPs, and/or familiarity with standard clinical operating procedures is a plus.
Must be able to work both independently and as part of a team.
Has experience with managing paper and electronic TMF studies.

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