Clinical Quality Compliance Associate
Any US Location (Preferred locations: San Antonio, TX/Durham, NC)
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. As a Clinical Quality Compliance Associate you will be an expert advisor on ICH GCP, ICON SOPs/WPs and all stages of study set-up, monitoring and study close-out for assessment of quality compliance processes for monitoring activities; become involved, when required, in other areas of services and staff training and contribute to the review of ICON systems and quality procedures as appropriate; assist in tracking departmental quality compliance in processes and departmental metrics.
Overview of the role
Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance
As a member of staff, the employee is expected to embrace and contribute to our culture of processimprovement with a focus on streamlining our processes adding value to our business and meetingclient needs
Travel (approximately 65%) domestic and/or international
Assist the relevant operational staff in the implementation and tracking of clinical quality plans at the department and study level
Assessment of quality compliance processes for monitoring activities.
Identify potential non compliance/breaks of quality control steps taken by operations as measuredthru SOP, WP and industry standards
Escalation as appropriate to senior management with proposed solutions
Assessment of quality compliance processes for TMF to identify gaps, assist with corrective
Assess and assist project teams with quality control processes for monitoring trip reports and review cycle times are achieved personallyfor selected studies to ensure the monitoring plan is followed, issues are resolved and/or escalated
Prepare reports of QC trends as required by management
Assist in the implementation and tracking of corrective and preventative action plans for thedepartment and/or projects when required.
Provide QC services to other operational departments/vendors, as required.
Assist the quality compliance team in providing administration and project tracking support of QCrelated issues
Logging and tracking of study documentation and trial progress when required
Attending internal and external meetings, assisting in the production of presentation materials,generating meeting minutes
Contacting external and internal individuals to collate relevantstudy information
Other duties as assigned
Bachelor's degree or local equivalent preferably in science or RN. Other relevant experience may be considered in lieu of the above
Good working knowledge of Word, Excel, Outlook and PowerPoint.
Excellent written and oral communication skills.Excellent organizational skills
Good knowledge and understanding of GCP regulations, EU Directives and guidelines
Ability to manage time and work independently
Due to the nature of this position it may be required for the employee to travel. Therefore, dependenton the employee's location, the employee may be required to possess a valid Drivers license
US/LATAM/CAN: A minimum of 4 years of relevant health care industry experience (PharmaceuticalCo, CRO or FDA). Recommended experience in the GCP, GLP, or GMP compliance area
EUIAPAC: Prior relevant experience of relevant health care industry experience (Pharmaceutical Co,CRO or FDA). Recommended experience in the GCP, GLP or GMP compliance area
Benefits of Working in ICON
Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent pension scheme, private health care, life assurance and staff recognition schemes. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment
US-Any US location
Clinical - Operations
06/Nov/13, 3:31:45 PM
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