Quality Assurance Specialist

SGS North America Inc.; Phoenix (AZ); On-site; USD 65,000 - 90,000; Full time

Job summary

SGS North America Inc. in Phoenix, AZ, is seeking a clinical study auditor to review protocols, consent forms, and CRFs to ensure early study integrity and GCP/ICH compliance.

The role involves audits of internal departments and collaboration with international coordinators to guarantee accurate documentation for clients. The successful candidate will analyze marketing and recruitment materials for compliance, audit study materials and sponsor reports, and assist with training of new

Qualifications

• Associates degree and 2–4 years of relevant experience.
• Bachelor's degree with 1–3 years of relevant experience.
• Understanding of clinical studies and regulatory guidelines.

Responsibilities

• Review protocols, informed consents, and case report forms prior to study initiation.
• Audit internal departments and ensure documentation accuracy for clients.
• Coordinate with international coordinators and project managers for compliant documentation.
• Review marketing and recruiting materials for compliance.
• Audit study material receipt and destruction; review sponsor Final Report.
• Assist with training and monitor internal studies.

Skills

Attention to detail

Organizational skills

Interpersonal skills

Multitasking

GCP/ICH/GLP knowledge

NIH training

Education

Associate degree

Bachelor's degree

Tools

Internal auditing training

Job description

Full-time

Company Description

SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services. Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.

Job Description

• Performs review of protocols, informed consents, and case reports forms (CRFs) prior to study initiation and revised documents
• Performs audits of internal departments as required.
• Works directly with international coordinators and project managers to ensure accurate documentation is performed for clients
• Performs review of marketing and recruiting documentation
• Performs audit of study material receipt and return/destruction
• Performs in clinic monitoring of study procedures per associate clinical study
• Conducts audits of clinical trial master files, source data, and procedures for protocol, monitoring plan (when applicable) SOP, and GCP/ICH compliance
• Performs review of sponsor Final Report
• Assists with auditing the company training files
• Monitors internal studies and alternative sites
• Assist with documentation of root-cause analysis stemming from internal non-conformities, corrective actions, and preventive actions
• Assist in the review of clinical study protocol deviations
• Training of new departmental staff
• Work with all involved parties to ensure that both the equipment and operational needs are met

Qualifications

• Associates and min of 2 -4 years of relevant experience
• Bachelor's and min 1-3 years of relevant experience
• Demonstrated ability to understand clinical studies
• Excellent organizational, attention to detail, interpersonal skills, and possesses a high level of multi-tasking capacities
• Knowledge of GCP ICH/GLP guidelines and Federal Regulations related to the conduct of Clinical Trails, NIH training
• Preferred: ISO 19011 Internal Auditing Training- preferred

Additional Information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy applyJob LocationGoogle Maps requires functional cookies to be enabled