Quality Assurance Specialist

• 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
• Bachelors 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 companys 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 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.

Remote Work :

No

Employment Type :

Full-time