We're seeking a Full Time Quality Assurance Coordinator to join our team who will ensure that high standards of data quality and subject safety are maintained, as well as study protocols, SOPs/SWPs, ICH/GCP and IRB guidelines, federal regulations are consistently being followed. This position is Monday-Friday from 8am-5pm.

ABOUT US

Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.

JOB SUMMARY

Ensure that high standards of data quality and subject safety are maintained, as well as study protocols, SOPs/SWPs, ICH/GCP and IRB guidelines, federal regulations are consistently being followed.

DUTIES AND RESPONSIBILITIES DESCRIPTION

Assist the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines

Review follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis

Perform 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

Perform quality review of initially created source documentation, including amendments, to ensure all protocol required procedures are present

Provide training and education on SOPs, GCP, and federal regulations as appropriate Prepare for internal and external audits

Attend staff meetings

Attend site initiation visits as needed

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.

Assist the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines

Review follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis

Perform 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

Perform quality review of initially created source documentation, including amendments, to ensure all protocol required procedures are present

Provide training and education on SOPs, GCP, and federal regulations as appropriate

Prepare for internal and external audits

Attend staff meetings

Attend site initiation visits as needed

Remote source review

Managing ICF review/approval process

Providing assignments, training & directives to QAA's

Managing the deviation tracker.

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.

Education: Bachelors degree or equivalent preferred

Experience: Minimum 1-2 years relevant experience

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

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.

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.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• High school or equivalent (Preferred)

Experience:

• Quality assurance: 1 year (Required)

Ability to Relocate:

• Decatur, GA 30030: Relocate before starting work (Required)

Work Location: In person