Sr. Clinical Research Associate

Location: Pleasonton, CA, United States
Date Posted: 05-13-2016


Location: Pleasonton, CA.
Job Title: Senior Clinical Research Associate / Principal Clinical Research Associate

Department: Medical Affairs Department

Reports to: Manager, Clinical Operations or higher

Objectives of the Position

To lead and ensure timely implementation of clinical research plans for assigned products or

product lines

To independently coordinate and execute clinical research activities for complex multisite

clinical studies

Scope

Support the evaluation of RMD products

Description of Responsibilities:

Provide technical input to study designs, clinical development plans and protocols

Work with Data Management and Biostatistical staff on the design of documents and processes

for the collection, transfer and analysis of study data from study sites

Execute assigned studies per plan

Manage assigned studies through all phases of study process

Plan and manage project budgets, resources and schedules

Plan, forecast and manage study logistics

Develop study operation documents and data collection forms (e.g. CRFs)

Identify, qualify, train and manage study sites, including site monitoring visits

Conduct and document study per protocol, Good Clinical Practices (GCP) guidelines and

SOPs. Ensure study site compliance with regulatory requirements

Serve as first line technical expert on assay and system

Troubleshoot and document instrument problems on assigned projects

Review clinical reports, manuscripts and other publication documents. Contribute technical and

clinical operations expertise for these documents

Actively represent department on project teams and Life Cycle Teams as assigned

Represent RMS at study sites, investigator meetings and conferences

Maintain and expand knowledge and expertise to support Clinical Operation's responsibilities

B.S. or M.S. in Biology, Chemistry, Molecular Biology or related discipline.

Sr. CRA / Principal CRA requires a minimum of 7+ years relevant work experience with 5+ years of

CRA experience. Preferably, 8-10+ years relevant work experience.

The candidate must be an extremely detail oriented "people person , a self starter with excellent lab

skills. He or she must be able to work in a team situation, have the ability to solve problems in a

detailed, comprehensive manner, demonstrate urgency and energy to handle problems, meet

timelines and manage sites. He or she must have excellent written and verbal communication skills,

and good presentation skills. Additionally, MSWord, Excel, and Powerpoint skills are required. Up

to 35% travel may be required.

Clinical Operations Group



Central Business Solutions, Inc,
37600 Central Ct.
Suite #214
Newark, CA 94560.
Central Business Solutions, Inc(A Certified Minority Owned Organization)
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Central Business Solutions, Inc
37600 Central Court Suite 214 Newark CA, 94560
Phone: (510)-713-9900, 510-573-5500 Fax: (510)-740-3677
Web: http://www.cbsinfosys.com
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