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18 days old

Clinical Trials Research Auditor

Kelly Services
Portland, OR 97240
**Kelly Services is actively recruiting for a Direct-Hire opportunity for a** **Clinical Trials Research Auditor in Portland, OR.**


**This is a hybrid remote/onsite role - must be located in Portland.**


The Clinical Trials Research Auditor will conduct routine audits of clinical trial related-documents including but not limited to case report forms, patient files, and study protocols and reports. Incumbent will be expected to report and follow-up on audit findings and corrective actions as applicable.


MAJOR CHALLENGES: Managing multiple priorities and establishing a positive rapport with consortium sites being monitored


Essential Duties and Responsibilities include the following:


Responsible for the completion of routine audits and monitoring activities for clinical trials including, but not limited to, the review of case report forms, study files, study protocols, and internal processes.


Assists with the development and implementation of audit plans aimed at monitoring the compliance of clinical trials to applicable regulations, policies, and procedures.


Contributes in developing and utilizes research audit tools that assess the quality indicators.


Identifies areas of deficiency in quality and reports those to leadership and other appropriate personnel.


Ensures that audit findings have been adequately reported; contributes in the preparation, implementation, and follow-up of corrective action plans. Assists research staff in maintaining FDA compliance.


Assists with development and revisions of departmental SOPs.


Additional responsibilities as assigned.


Travel will be required for monitoring activities at external research sites.


Education and Experience:


Bachelor's Degree Preferably medically oriented.


Three years Relevant experience in a quality assurance, regulatory affairs, or clinical research/study coordination function preferred


Familiarity with GXPs (e.g., GCP, GMP, GLP) required.


Thorough knowledge and understanding of FDA GCP, ICH guidelines as well as other Federal, State and Local regulations for research administration preferred.


Strong interpersonal skills and ability to interface with institutional faculty, administrators, industry sponsors and regulatory agencies.


Ability to be flexible, multitask and switch priorities as well as work comfortably in a deadline driven environment.


Effective written, verbal communication skills including presentation skills.


Strong strategic and planning skills, attention to detail, and ability to solve complex problems.


Strong knowledge of medical and clinical research terminology.


High level of proficiency with MS Office products including Outlook, Word, and Access.


Computer System, Internet Data Submission systems.


SoCRA certification (or professional certification in a related field, such as Regulatory, QA, or Clinical Research) preferred, not required.


Schedule M-F day business hours


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-06-06 Expires: 2022-07-25

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Clinical Trials Research Auditor

Kelly Services
Portland, OR 97240

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