We opened our doors with a clear and simple vision: to provide the worldwide clinical research industry with professional services that demonstrate the highest level of experience, quality, and integrity. Since 1996, ProTrials has supported research that has led to ground-breaking treatments and solutions in the pharmaceutical, biotechnology, and medical device industries.
What fuels our focus? Most of us entered the clinical research field to help patients, caregivers, or maybe even our loved ones. We show up every day committed to do work that matters. When you join ProTrials, you will join a collaborative community helping to build a healthier world.
We also understand your need to balance a meaningful workload with life’s every-day moments. At ProTrials, we know that this makes our employees happier, healthier, and more successful.
SUMMARY:
The Clinical Quality Assurance Consultant will provide consultation in the interpretation of good clinical practice (GCP) regulations, guidelines, policies, and procedures. The Clinical QA Consultant will plan, conduct, and report on independent audits of internal systems/ procedures and vendors. The QA Consultant supports, maintains, and reviews QA systems, corporate training programs, and corrective action and preventative actions (CAPAs).
ESSENTIAL DUTIES:Prepare, coordinate, and/or host client and/or regulatory auditsManage annual internal and vendor audit programsConduct QA audits (internal systems and vendor, and investigator site audits)Collaborate in SOP writing and/or reviewWrite, review, and track CAPAsReview & approve audit plans to ensure they are adequate and reflective of the needs identified from risk assessment strategiesSupport and/or provide management with quality metrics and updatesAssess internal and external quality information inputs to quickly adjust QA activities or initiativesIdentify and coordinate training within the QA departmentAdvise, as needed, on quality assurance and compliance topicsLead and/or participate in identified QA initiatives and projectsOTHER QUALIFICATIONS:Strong knowledge of FDA, GCP, and ICH regulations, guidelines, and standards governing regulated clinical research requiredWorking knowledge and understanding of drug development and global clinical regulatory environmentInsightful, decisive, proactive, and solutions-orientedProven excellence in professional skills including communication, organization, prioritization, discretion, and accuracyExceptional customer service skills, including cultivating and maintaining close working relationships with both internal and external stakeholdersProficiency in MS Office including Word, Excel, PowerPoint, Outlook, SharePoint, OneNote, and virtual meeting softwareFlexibility with shifting prioritiesAvailable to travel as neededEDUCATION AND/OR EXPERIENCE:Bachelor’s degree in scientific or related discipline, or equivalent work experienceMinimum of 5-7 years industry experience, with at least 3-5 years in clinical QADirect experience with internal/external clinical systems and process auditsExperience in QA audits of Clinical Investigator sites and clinical vendorsExperience in development of SOPsStrong software and computer skills; including MS Word, Excel, PowerPoint, and OutlookExcellent presentation skillsExcept as otherwise permitted or required by applicable law or regulatory requirements, ProTrials will retain the applicant’s personal information in accordance with its statutory obligations and internal policies and procedures.
Information collected during application completion may be retained for a reasonable period of time and in accordance with the company’s established retention policies. Applicants seeking more information may contact
HR@ProTrials.com.
ProTrials Research, Inc. is an equal opportunity employer. ProTrials does not discriminate against qualified applicants or employees with respect to any terms or conditions of employment based on race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.
