Position Overview:
A Senior CRA to ensure all aspects of clinical operations and development, regulatory affairs, and medical affairs activities are in compliance with governing regulations requirements.
Responsibilities:
- Perform all required activities to ensure appropriate management of investigator sites are conducted as per ICH GCP, Ethics and Regulatory requirement and the sites SOPs.
- Independently manage, conduct, and report assigned investigator site, vendor, and internal process/function audits on site
- Independently perform document record review, including general study files and site-specific study files
- Provide audit activities summary reports to management
- Complete site visits in accordance with relevant SOPs, regulatory requirements and guidelines, the study protocol, project plan
- Perform other duties as assigned
Skill Requirements
- MS degree or BS/BA degree with three (3) additional years of experience may be substituted..
- Minimum Experience ten (10) years of related experience
- Must demonstrate experience with FDA regulatory requirements.
- Must demonstrate experience and working knowledge of ICH, GCP and regulatory agency requirements both domestically and internationally
- Must have experience in working with multi-disciplinary teams across various aspects of clinical trial development.
- Must have a high proficiency of written and spoken English.
- Must have proficiency with an office productively suite such as Microsoft Office, Adode, MS Word, Excel, and Outlook especially electronic spreadsheet functions and word processing software
- Demonstrates critical thinking skills and attention to detail
- Excellent communication skills, both written and verbal, and the ability to give and receive honest and direct feedback
- Excellent teamwork and interpersonal skills, with calm demeanor and positive attitude under pressure
- Must be available to travel 25 % of time
Equal Opportunity Employer
Minorities/Women/Veterans/Disabled
NUES INCis an equal opportunity employer. Our policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category.
Applicants must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.
The Company will not sponsor applicants for work visas.‘
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Work Location:
- Multiple locations
Work Remotely
- Temporarily due to COVID-19
Job Types: Part-time, Temporary
Pay: $75.00 – $105.00 per hour
Education:
- Bachelor’s (Required)
Experience:
- CRA: 10 years (Required)
- Monitoring Clinical Trials: 10 years (Required)
- GCP Audits: 5 years (Preferred)
- Clinical trials: 10 years (Required)
- Human Subject Protection: 10 years (Required)
License/Certification:
- Certified Clinical Research Professional (CCRP) (Required)
Willingness to travel:
- 25% (Required)
Work Location: Multiple Locations