Quality Assurance Coordinator

CenExel; Decatur (GA); On-site; USD 53,000 - 55,000; Full time

Job summary

A leading clinical research company in Decatur, Georgia, seeks a dedicated professional to ensure data quality and participant safety in studies. Responsibilities include assisting in quality assurance programs, conducting reviews, and preparing for audits. Ideal candidates should have 1-2 years of experience in clinical research, strong communication skills, and knowledge of FDA regulations and GCP guidelines. The position demands a detail-oriented approach and offers an on-site work environment with competitive compensation and opportunities for professional growth.

Qualifications

• Minimum 1-2 years relevant experience in the clinical research industry.
• Must have in-depth knowledge of FDA regulations, GCP, and ICH guidelines.
• Motivated to work consistently in a fast-paced environment.

Responsibilities

• Assist the QA Manager in the development of quality assurance programs.
• Review follow-up monitoring visit reports and quality findings trackers.
• Prepare for internal and external audits and inspections.

Skills

Verbal communication

Written communication

Detail-oriented

Organizational skills

Knowledge of FDA regulations

Knowledge of GCP guidelines

Knowledge of ICH guidelines

Education

High school diploma or equivalent

Bachelor's degree or equivalent

Job description

Compensation

$53,000 - $55,000/year depending on education, experience, and skillset

Job Summary

Ensure that highest standards of data quality and study participant safety are maintained, as well as adherence to study protocols, CenExel SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines.

Essential Responsibilities and Duties

• Assists the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines.
• Reviews follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis.
• Performs ongoing review of a percentage sampling of study inclusion/exclusion, study procedure records, and laboratory reports to ensure that they are conducted according to the protocol, applicable SOPs, ICH/GCP guidelines and federal regulations.
• Performs quality review of initially created source documentation, including amendments, to ensure all protocol required procedures are present.
• Prepares for internal and external audits and FDA inspections.
• Attends staff meetings.
• Attends site initiation visits as needed.
• Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
• Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.

Education/Experience/Skills

• Must be able to effectively communicate verbally and in writing.
• High school graduate or equivalent, Bachelors degree or equivalent preferred.
• Minimum 1-2 years relevant experience in the clinical research industry.
• Knowledge/Skills/Abilities: Must be self-directed and able to work with minimal supervision; must have in depth knowledge of FDA regulations, GCP, and ICH guidelines; able to take a flexible approach to shifting priorities; able to manage multiple projects and responsibilities; motivated to work consistently in a fast paced and rapidly changing environment; must be detail oriented and have exceptional computer, organizational, and communication skills – both written and oral.
• Must reflect the professional image of the company, upholding the company vision in actions, demeanor, and appearance.
• Must be able to clearly communicate through written and verbal means with sponsors and staff.

Working Conditions

• Indoor, Office environment.
• Essential physical requirements include sitting, typing, standing, walking.
• Lightly active position, occasional lifting of up to 20 pounds.
• Reporting to work, as scheduled, is essential.
• On-site work arrangement.

CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.