Associate Clinical Trial Management

Associate Clinical Trial Management
Company:

Software Guidance & Assistance


Associate Clinical Trial Management

Details of the offer

Site Manager
(Associate, Regional Site Manager (Regional Site Manager))
Location: Irvine, CA
Bill : $55.72 HR

Responsibilities
:

Supports CTM/OSL in ensuring the assigned clinical study(ies) are run on time and to budget and are completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Client policies and procedures

Assist CTM/OSL with:regional site feasibility, when necessary o tracking of site training, certification, delivery of ancillary supplies, etc. Necessary for site activation

Development of study-specific documents, when necessary

Regional vendor management: manage vendor issues, coordinate contract amendments, create monthly vendor accruals, process and track monthly invoices, provide quarterly budget forecast assumptions

Periodic review of protocol deviations o database lock activities (interim or final lock)

Regional study drug management track shipping or storage site temperature excursions

Regional trial master file management (tmf): ensure all documents are appropriately filed in the TMF

Regional enrollment management: site activation and enrollment tracking for monthly reporting

Experience
:

Experience supporting clinical trials

Handle and prioritize multiple tasks simultaneously

Work effectively in a team/matrix environment o Understand technical, scientific and medical information

Handle conflict management and resolution

Familiarity with clinical study budgets and accruals

Knowledge
:

Candidate must have a good understanding of the following:

Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based)

Knowledge of concepts of clinical research and drug development

Prefer but not a must have - Ophthalmology area experience

Qualifications
:

Bachelor's degree or higher o Science degree preferably in science or health-related field

Previous experience of working on a clinical study


Source: Dice


Area:

Requirements

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