CenExel
Overview
Quality Assurance Coordinator role at CenExel. CenExels research sites specialize in Phase I to Phase IV clinical trials with Centers of Excellence across Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Our sites have in-patient capability and focus on quality people, teamwork, and 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 provides competitive compensation and a generous benefits package to full time employees after 30 days of employment, including Health Insurance, Dental, Vision, LTD, STD, Life Insurance, and 401k. Job Summary
Ensure that the 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
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 and FDA inspections Attend staff meetings Attend site initiation visits, as needed Support and ensure strictest adherence to best practices, FDA CFR, ICH, GCP, CenExel SOPs, site Working Practices, protocol, and company guidelines and policies Assume other duties and responsibilities as assigned Education/Experience/Skills
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 Knowledge/Skills/Abilities: Self-directed, able to work with minimal supervision; in-depth knowledge of FDA regulations, GCP, and ICH guidelines; able to manage multiple projects in a fast-paced environment; detail-oriented with strong computer, organizational, and communication skills 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 On-site work arrangement CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or other protected status. Seniority level
Entry level Employment type
Full-time Job function
Quality Assurance Industries Research Services
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Quality Assurance Coordinator role at CenExel. CenExels research sites specialize in Phase I to Phase IV clinical trials with Centers of Excellence across Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Our sites have in-patient capability and focus on quality people, teamwork, and 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 provides competitive compensation and a generous benefits package to full time employees after 30 days of employment, including Health Insurance, Dental, Vision, LTD, STD, Life Insurance, and 401k. Job Summary
Ensure that the 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
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 and FDA inspections Attend staff meetings Attend site initiation visits, as needed Support and ensure strictest adherence to best practices, FDA CFR, ICH, GCP, CenExel SOPs, site Working Practices, protocol, and company guidelines and policies Assume other duties and responsibilities as assigned Education/Experience/Skills
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 Knowledge/Skills/Abilities: Self-directed, able to work with minimal supervision; in-depth knowledge of FDA regulations, GCP, and ICH guidelines; able to manage multiple projects in a fast-paced environment; detail-oriented with strong computer, organizational, and communication skills 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 On-site work arrangement CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or other protected status. Seniority level
Entry level Employment type
Full-time Job function
Quality Assurance Industries Research Services
#J-18808-Ljbffr