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Clinical Research Associate

Clinlab Staffing


Location:
San Diego, California
Date:
09/25/2017
2017-09-252017-10-25
Job Status:
Full Time
Categories:
  • Clinical Operations
Clinlab Staffing
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Job Details

The Clinical Research Associate (CRA) is responsible for providing assistance to the Clinical Operations Department with activities related to the daily management of clinical operations. The CRA takes direction from Clinical Operations Management as assigned. The Clinical Research Associate reports to a Sr. Project Manager.

DUTIES & RESPONSIBILITIES:

Assist with the review, collection and tracking of clinical trial documents and/or site information, such as informed consent forms, study amendments, etc., and assist Clinical Operations Management with essential document submission and tracking

Assist with preparation of study files for audits

Assist in house and regional CRAs by providing pre- and post- visit support as needed.

The CRA may accompany experienced CRAs on monitoring visits at clinical sites including Pre-Study, Interim Monitoring and Close-Out Visits for hands on training and mentoring. Such visits will require contribution in post visit report writing and other efforts to demonstrate learning. Any such visit will be attended by a CPM or APM to provide guidance and mentoring

With guidance and mentoring from the Clinical Operations Management , assist with the development of study specific training materials, newsletters site communications i.e. disseminating study information, answering routine study questions, etc. and vendor communications

Establish and maintain both hard copy and electronic study files on the Clinical Drive and/or CTMS system

Attend regularly scheduled operations meetings and prepare/distribute team meeting minutes as required

Assist with clinical trial support and projects based on study needs Other duties as assigned commensurate with experience and workload

Provide executive administration support on a need basis

Become knowledgeable about drug development

QUALIFICATIONS/REQUIREMENTS:

2+years of experience with a pharmaceutical company, contract research organization, academic institution, or site management organization preferred

Basic understanding and proficiency in ICH / GCP, FDA, local regulations and clinical trials research processes and systems

Strong verbal and written communication skills with ability to communicate and work productively in a team environment

Proficient computer skills i.e. Microsoft Project, Word, PowerPoint, and Excel

Excellent organizational skills is essential, ability to work independently and with moderate guidance

Increasingly responsible position with opportunity to grow

Must have a valid driver’s license and be willing to travel up to 10% (mostly domestic)

Coordinate with multiple vendors offering a wide spectrum of services with guidance of Clinical Operations Management as needed

Job Type: Full-time

Required education:

Bachelor's

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