Senior Quality Specialist (Clinical Trials)
Title:
Senior Quality Specialist Location:
New Haven, CT Schedule:
M-F 37.5 hours, occasional weekend and evening hours Type:
Direct Hire Our client is seeking an individual with strong background in quality and/or compliance for clinical trialsSome monitoring or experience running internal QA auditing type programs idealRequirements:
Bachelor's Degree in degree in a health-related discipline, or other related field, and a minimum 5 years' experience working in a clinical research environment, or an equivalent combination of education and related experienceDemonstrated mastery of human subjects research related standards and ability to interpret, analyze, apply, and communicate applicable ethical principles, laws, regulations, guidance, policies, academic & industry trends, and other standardsDemonstrable understanding of clinical research review, approval & monitoring processes from start-up to close-outStrong computer skills required, including strong competency in Microsoft Office programs (Word, Excel, PowerPoint, etc.)Oncology clinical research experience strongly preferredPreferred competency with Clinical Trials Management Systems (CTMS) and Electronic Medical Record (EMR) systemsPreferred Licenses or Certifications:
SOCRA/ACRP (or equivalent) certification preferred
Responsibilities:
The SrQuality Specialist is responsible for assessing the quality of clinical trials conductedThis position participates in all aspects of clinical research integrity, compliance and privacy initiatives, including workforce orientation, incident response and documentation, clinical research monitoring and quality reviews, staff education on clinical research compliance topics, and providing support for policy and procedure developmentConducts risk based internal monitoring and quality control reviews of supported studies and research activities, with a focus on moderately to highly complex studies, and reviewing compliance with study protocols, Good Clinical Practices, and policies and proceduresWork with Director, Quality and Education to provide feedback, deficiencies and common trends identified in quality review to ensure timely and effective change control to improve overall qualityLeads the internal monitoring and quality control review effort by mentoring and the planning and conduct of monitoring and quality reviewsDevelops corrective and preventive actions (CAPAs) in collaboration with Clinical Research Managers and leaders, when issues are detected in order to avoid further deviations or other compliance issuesAlso responsible for quality follow-up on CAPAs that are implemented, in order to ensure adherence and effectivenessCoordinates and manages the preparation of all external audits conducted by study sponsorsCollaborates and supports Quality Assurance & Monitoring team on regulatory authority (e.g.:
FDA, EMA) inspection preparedness for CTO supported trials as neededPartner with the SrTraining Specialist to educate and provide guidance to staff members concerning internal processes and procedures which ensure that all aspects of clinical studies are conducted according to Good Clinical Practice GuidelinesM3 Recommended Skills Auditing Clinical Research Coaching And Mentoring Corrective And Preventive Action (Capa) Ethics Good Clinical Practices (Gcp) Apply to this job. Think you're the perfect candidate? Apply on company site $('.external-apply-email-saved').on('click', function (event) window.ExternalApply = window.open('/interstitial?jobdid=j3p1q56x0nmcl7ljwl4', 'ExternalApply-j3p1q56x0nmcl7ljwl4'); ); $(document).ready( function() $(#ads-desktop-placeholder).html(
n
n
n Estimated Salary: $20 to $28 per hour based on qualifications.
Senior Quality Specialist Location:
New Haven, CT Schedule:
M-F 37.5 hours, occasional weekend and evening hours Type:
Direct Hire Our client is seeking an individual with strong background in quality and/or compliance for clinical trialsSome monitoring or experience running internal QA auditing type programs idealRequirements:
Bachelor's Degree in degree in a health-related discipline, or other related field, and a minimum 5 years' experience working in a clinical research environment, or an equivalent combination of education and related experienceDemonstrated mastery of human subjects research related standards and ability to interpret, analyze, apply, and communicate applicable ethical principles, laws, regulations, guidance, policies, academic & industry trends, and other standardsDemonstrable understanding of clinical research review, approval & monitoring processes from start-up to close-outStrong computer skills required, including strong competency in Microsoft Office programs (Word, Excel, PowerPoint, etc.)Oncology clinical research experience strongly preferredPreferred competency with Clinical Trials Management Systems (CTMS) and Electronic Medical Record (EMR) systemsPreferred Licenses or Certifications:
SOCRA/ACRP (or equivalent) certification preferred
Responsibilities:
The SrQuality Specialist is responsible for assessing the quality of clinical trials conductedThis position participates in all aspects of clinical research integrity, compliance and privacy initiatives, including workforce orientation, incident response and documentation, clinical research monitoring and quality reviews, staff education on clinical research compliance topics, and providing support for policy and procedure developmentConducts risk based internal monitoring and quality control reviews of supported studies and research activities, with a focus on moderately to highly complex studies, and reviewing compliance with study protocols, Good Clinical Practices, and policies and proceduresWork with Director, Quality and Education to provide feedback, deficiencies and common trends identified in quality review to ensure timely and effective change control to improve overall qualityLeads the internal monitoring and quality control review effort by mentoring and the planning and conduct of monitoring and quality reviewsDevelops corrective and preventive actions (CAPAs) in collaboration with Clinical Research Managers and leaders, when issues are detected in order to avoid further deviations or other compliance issuesAlso responsible for quality follow-up on CAPAs that are implemented, in order to ensure adherence and effectivenessCoordinates and manages the preparation of all external audits conducted by study sponsorsCollaborates and supports Quality Assurance & Monitoring team on regulatory authority (e.g.:
FDA, EMA) inspection preparedness for CTO supported trials as neededPartner with the SrTraining Specialist to educate and provide guidance to staff members concerning internal processes and procedures which ensure that all aspects of clinical studies are conducted according to Good Clinical Practice GuidelinesM3 Recommended Skills Auditing Clinical Research Coaching And Mentoring Corrective And Preventive Action (Capa) Ethics Good Clinical Practices (Gcp) Apply to this job. Think you're the perfect candidate? Apply on company site $('.external-apply-email-saved').on('click', function (event) window.ExternalApply = window.open('/interstitial?jobdid=j3p1q56x0nmcl7ljwl4', 'ExternalApply-j3p1q56x0nmcl7ljwl4'); ); $(document).ready( function() $(#ads-desktop-placeholder).html(
n
n
n Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
