Quality Assurance Coordinator (Clinical Research)
Company: SGS Group
Posted on: January 13, 2022
SGS is the world's leading inspection, verification, testing, and
certification company. SGS is recognized as the global benchmark
for quality and integrity. With more than 94,000 employees SGS
operates a network of over 2,600 offices and laboratories around
As the Quality Assurance Coordinator, you will be responsible for
ensuring compliance with protocols, federal regulations, industry
guidelines and company procedures. Maintain knowledge of Good
Clinical Practices (GCP), Standard Operating Procedures (SOP), and
Federal and applicable regulations.
Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions.
- Performs review of protocols, informed consents, and case
reports forms (CRFs) prior to study initiation and revised
- Performs review of marketing and recruiting
- Performs audit of study material receipt and
- Performs in clinic audit of study procedures
- 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 Final Report
- Assists with auditing the company training files
- Monitors alternative sites
- Assist with documentation of non-conformities, corrective
actions, and preventive actions
- Assist with training of new departmental staff
- Other duties or tasks assigned by manager
- Work with all involved parties to ensure that both the
equipment and operational needs are met.
- Oversee that the lab safety and orderly contact and take prompt
corrective action when unsafe conditions, practices, or equipment
are reported or observed.
- Encourage prompt reporting of health and safety concerns.
- High School diploma or equivalent
- 0-2 years of job related experience
- Demonstrated ability to understand clinical studies
- Excellent organizational, attention to detail, interpersonal
skills, and possesses a high level of multi-tasking
- Knowledge of GCP ICH/GLP guidelines and Federal Regulations
related to the conduct of Clinical Trails, NIH training
- CCRA Certification preferred
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
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 callback. 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.
Keywords: SGS Group, Richardson , Quality Assurance Coordinator (Clinical Research), Healthcare , Richardson, Texas
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