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Job Code: #15690
Title: Clinical Research Associate II
Job Location: Tucson, Arizona

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Job Description:

Our client in Tucson, AZ has an immediate need for a Clinical Research Associate II.  Please forward your resume to tucsonjobs@pdsinc.com for immediate consideration. 

POSITION SUMMARY:

Responsible for the conduct and management of clinical study activities to verify and validate new instrument
platforms, assays and biomarkers. 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).   

ESSENTIAL FUNCTIONS: 

The following study related tasks are fundamental to this position, but they may be expanded or omitted at the
discretion of the Clinical Manager to more effectively complete clinical research activities: 

Site Management & Monitoring: 
Conducts most aspects of site management and independently monitors study activities according to Standard Operating Procedures, ICH GCP guidelines and Regulations.  May serve as
lead CRA for assigned studies. 
Conducts study risk assessments and applies the principles of risk-based monitoring.
Communicates with investigators and site staff across multiple studies.
Establishes key performance indicators prior to study initiation, and provides input into corrective action for 
study performance issues.
 
Study Implementation:
Drafts and finalizes associated documentation and independently manages one or more projects including: 
Study training presentations for investigators and site staff.
Study supply ordering and shipping. 
Investigational product release, labeling, accountability at study sites.
Site Readiness and Site Monitoring Plans.
Assay transfer and assay qualification activities.
Study records including site and trial master files.
Site qualification, site initiation, routine monitoring and close out visits and reports. 
Document compilation for clinical study reports and document archive activities. 
Data management activities including user acceptance testing, data entry, and data verification as needed. 

Departmental Roles: 
Works across multiple project teams, indications, and differing study designs.
Participates in clinical affairs meetings, and may represent the department on cross functional project 
teams, interfacing with representatives from other functional groups including: quality, product development, manufacturing, marketing, customer service and regulatory affairs. 
Completes all internal training programs in a timely manner, and acquires professional, product and market expertise via independent reading, networking and training. 
Proactively supports improved clinical processes within the Quality System to ensure Quality First Time. 

MINIMUM QUALIFICATIONS:

Formal Training/Education:  
Bachelor of Science, RN or BSN preferred; OR equivalent combination of education and clinical experience. 
 
Experience:
4+ years clinical research experience.  
2+ years of in-house CRA experience or IVD study experience preferred.
Extensive background in biomedical/healthcare services with laboratory experience preferred.
Previous experience with investigational product management, case report form (CRF) development, 
protocol or report writing, and data management.
Familiar with good documentation practices, record retention requirements, and processes to assess, 
qualify, initiate, monitor and close investigational sites.
 
Knowledge, Skills and Abilities:
Knowledge of current Good Clinical Practices (cGCP) and Regulations. 
Knowledge of typical experimental designs to characterize the performance of an IVD or Medical Device.
Proficient with standard software applications (word processing, spreadsheets, presentations) as well as 
Microsoft Visio and Microsoft Project.  
Excellent written and verbal communication skills.
Well organized and detail oriented. 
Impeccable record keeping and filing skills.
Excellent time management skills. 
Excellent communicator. 
Ability to create effective presentations and teach others
Ability to work independently to identify and resolve issues with minimal supervision.
Ability to complete intermittent overnight travel up to 50%. 

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