PRQuality Mangement Coordinator
Profound Ethos • Physicians are the Vanguard • All Decisions Improve Patient Care • Never Compromise Quality
Role: Coordinator, Quality ManagementCompany: Profound ResearchLocation: Remote
Why this Role ExistsWe are seeking a skilled and motivated Quality Management professional to join our team. If you are passionate about conducting clinical quality data reviews and collaborating with clinical research teams to ensure quality, patient safety and data integrity, we want to hear from you. ResponsibilitiesAs Coordinator, Quality Management, you will play a pivotal role in ensuring the execution of clinical trials in accordance with regulatory requirements, industry standards and company policies by completing clinical quality data reviews. The successful candidate will collaborate with cross-functional teams (ex: clinical trial sites, regulatory, data management), conduct clinical trial data reviews, provide regulatory guidance to clinical trial personnel, support customer audits and FDA inspections and support efforts to continuously improve quality management practices. Key responsibilities include:
Clinical Quality Data Reviews: Conduct quality-focused reviews of clinical trial data and records, assessing compliance to the protocol, GCP, good documentation practices (GDP/ALCOA) and company policies.
Compliance Oversight: Collaborate with clinical study teams to ensure clinical trials comply with relevant regulatory requirements, Good Clinical Practices (GCP), protocols and company policies.
Issue Resolution: Collaborate with study team members to investigate and resolve quality-related issues and to complete root cause analysis (RCA) and corrective and preventive actions (CAPAs) as necessary.
Audit and Inspection Support: Prepare study teams for study/site-specific customer audits and regulatory inspections, including supporting responses and corrective actions as needed.
Training and Education: Support delivery of training programs for clinical trial personnel regarding quality management processes, GCP, GDP/ALCOA and other relevant topics.
Continuous Improvement: Support efforts to continuously improve clinical trial quality by employing best practices and bringing innovative solutions.
Quality Culture: Provide quality guidance to study teams. Foster a culture of quality and accountability, to ensure protection of participant safety and data integrity.· Performs other related duties as assigned. Note: This job description is intended to provide a general overview of the position and should not be considered an exhaustive list of responsibilities and qualifications. Responsibilities and qualifications may vary depending on the specific role and project requirements. Requirements· Bachelor's degree in a relevant scientific or healthcare field.· Minimum of 1 year experience in clinical quality within the pharmaceutical industry.· Strong knowledge of Good Clinical Practices and clinical trial regulations and guidance (ex: 21 CFR Parts 50, 54, 56, 312; ICH E6).· Proficient at reviewing clinical trial data and regulatory (essential documents) in both paper and electronic formats (i.e., electronic source and electronic regulatory systems).· Ability to collaborate effectively with cross functional teams and appropriately communicate potential issues.· Experience in leading root causes analysis (RCA) discussions and assisting study teams to identify appropriate corrective and preventive actions.· Experience preparing study teams for and supporting customer audits and/or regulatory inspections.· Detail-oriented with a strong commitment to quality and compliance.· Strong analytical skills and problem-solving abilities. Preferred Qualifications· Experience supporting clinical trial sites and/or site networks.· Experience using an electronic Quality Management System (QMS), CRIO and/or Complion.· Experience in roles such as clinical research coordinator.· Experience delivering GCP-related training to clinical study teams. Travel Requirements· Ability to travel up to 35%.Physical Requirements· Prolonged periods of sitting at a desk and working on a computer, standing and walking.· Must be able to lift 25 pounds at times.· Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.· Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.· Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound.· The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
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About the job
Apply before
Jul 13, 2024
Posted on
May 14, 2024
Job type
Full Time
Experience level
Mid-level
Location requirements
Open to candidates from all countries.
Hiring timezones
Worldwide
Job categories
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