The Clinical Auditor (CA) from IMARC Research, Inc. will work with a sponsoring company or CRO in the auditing of pharmaceutical or device trials with an emphasis placed on ensuring the highest ethical and clinical standards.
The primary focus of this position is to coordinate auditing activities, manage the auditing staff, and perform routine audits at clinical sites. The CA’s role is to perform clinical quality assurance (CQA) duties and audit trial conduct at investigative sites against ICH GCP regulations and guidelines, FDA regulations, Sponsor SOPs, Sponsor monitor plans, and audit-specific SOPs. The CA may also perform audits of Sponsors and CROs. The CA will serve as a resource person for the Sponsor, CRO, auditors and/or monitors, and advise on corrective action planning to make processes more compliant with regulations and guidelines. Additionally, the CA will be expected to manage the internal Quality Assurance program for IMARC Research, Inc.
This position requires travel up to 50% - 60% of the time. International travel may be required.
Knowledge, Skills, and Abilities
- At least 3 years of applicable experience in the clinical research industry (5+ years preferred)
- RN or BA/BS in a health-related science area
- Clinical research certification preferred
- Knowledge of medical terminology
- Working knowledge of US federal regulations related to clinical research studies, ICH Guidelines and GCP
- Ability to follow strict ICH GCP guidelines, FDA regulations, and audit-specific SOPs
- Ability to acquire knowledge of investigational products and different therapeutic areas of study
- Excellent organizational and communication skills
- Detail oriented
- Time management skills and problem solving abilities, including the ability to put a problem into context and suggest pragmatic and practical solutions
- Ability to assimilate information rapidly and adapt to different situations/demands
- Ability to work independently and with a team
- Excellent writing skills
- Ability to present self in a highly professional manner in all settings
- Computer proficiency, including the use of standard software (word processing, databases, e-mail) and the use of the internet
Salary commensurate with experience.
If you're interested in a career with IMARC, please send your resume to careers@imarcresearch.com.
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