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CenExel · 2 months ago

Quality Assurance Coordinator II (Clinical Research)

Decatur, GA

Full-time

Onsite

Entry, Mid Level

$23.65/hr - $35.35/hr

2+ years exp

CenExel is a company specializing in Phase I to Phase IV clinical trials across various specialty areas. The Quality Assurance Coordinator II role focuses on maintaining high standards of data quality and study participant safety while ensuring adherence to study protocols and regulatory guidelines.

Clinical TrialsHealth CarePharmaceutical

H1B Sponsor Likely

Responsibilities

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

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

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

Qualification

Quality Assurance experienceFDA regulations knowledgeGCP knowledgeICH guidelines knowledgeCommunication skillsOrganizational skillsSelf-directedFlexible approachDetail orientedManage projects

Required

Must be able to effectively communicate verbally and in writing

Must have proper experience and demonstrate mastery of Quality Assurance Coordinator I position

Minimum 2 years quality assurance experience

Must be self-directed and able to work with minimal supervision

Must have in depth knowledge of FDA regulations

Must have knowledge of 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

Benefits

Health Insurance

Dental

Vision

LTD

STD

Life Ins

401k

Company

CenExel

CenExel is a clinical research site network supporting phase I-IV clinical trials. It is a sub-organization of Webster Equity Partners.

Founded in 2018

Salt Lake City, Utah, USA

1001-5000 employees

http://www.CenExelresearch.com

H1B Sponsorship

CenExel has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (1)

2020 (1)