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Clinical Research Associate

Pleasanton, CA
Job Title : Clinical Research Associate
Location: Pleasanton, CA​.

 

JOB SUMMARY:
Responsible for the conduct and management of clinical study activities to verify and validate new clinical software, 
instrument platforms, assays and biomarkers developed by RMS. Works independently to complete CRA functions associated with study planning, 
implementation, monitoring and closing study conduct in accordance with the principles of Good Clinical Practice (GCP).


DISTINGUISHING CHARACTERISTICS:
This is a multiple incumbent job.

ESSENTIAL RESPONSIBILITIES:
Works under moderate guidance and participates in the planning and implementation clinical research projects; contributes technical and clinical operations expertise  
May co-ordinate the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well. 
Travels to field sites to monitor studies. 
Under moderate guidance; plans and prepares studies. 
Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents 
Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites. 
Collects and maintains legal and regulatory documentation, as applicable. 
Manages training and coordinating certification of study site personnel. 
Ensures accurate and complete study management/data collection and transfer to data management. 
Ensures site compliance with regulations and study protocol. 
Monitors the sites and provides technical assistance, as necessary. 
Manages material logistics for the studies. 
Conducts reference material testing in-house. 
Organizes investigator meetings, as necessary. 
May act as a lead for assigned projects and/or Project Team Meetings. 
Evaluates and escalates decisions impacting project team and/or work area(s) and/or broader organization.    
Maintains a high level of professional expertise through familiarity with scientific literature, Company product portfolio, and competitive environments.   
Processes and applies specific knowledge to the completion of difficult work assignments.      

MINIMUM QUALIFICATIONS:

Formal Training/Education:
Bachelor degree in scientific discipline or related field required, or equivalent combination of education and work experience. 

Experience:
5+ years of experience in clinical study coordination, clinical site monitoring or clinical study management is required, 7+ preferred.
Prior experience with current Good Clinical Practices (cGCP) and Code of Federal Regulations (CFR) is preferred.
A background in biomedical/healthcare services with laboratory experience preferred.


Knowledge, Skills, and Abilities:
Excellent skills in basic computer applications (Word, Excel, Access, PowerPoint). 
Excellent writing and verbal communication skills. 
Well organized and detail oriented. 
Impeccable record keeping and filing skills. 
Excellent time management skills. 
Ability to give presentations and teach others. 
Ability to work effectively in a team, and also work independently on assigned tasks 



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: (833)247-8800 Fax: (510)-740-3677
Web: http://www.cbsinfosys.com
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