clinical quality assurance specialist

Brown University Health

<div><ul><li>Job ID: JR-108149
</li><li>Entity: Rhode Island Hospital
</li><li>Location Name: Rhode Island Hospital
</li><li>City, State: Providence, RI
</li><li>Work Type: FULL TIME
</li><li>Hours Per Week: 40
</li><li>Shift: Day
</li><li>Posted Date: 4/10/2026
</li></ul><div><h2 class="jobSectionHeader"><b>SUMMARY</b></h2>
<p>
The Clinical Research Quality Assurance and Improvement (QA/QI) Specialist utilizes knowledge to:</p>
<ul>
<li>Analyze and interpret applicable regulations</li>
<li>Develop/revise institutional policies and procedures</li>
<li>Audit the conduct of human subjects research (biomedical, social &amp; behavioral) and research oversight programs</li>
<li>Assess compliance with all applicable regulations, guidance, and policies and procedures</li>
<li>Identify areas of risk</li>
<li>Oversee the development and implementation of corrective and preventive action plans</li>
</ul>
<p>Ensures adherence to the standards for the responsible conduct of research and compliance. Assists with preparation for external quality reviews and regulatory audits. Brown University Health employees are expected to successfully role model the organization's values of <b>Compassion</b>, <b>Accountability</b>, <b>Respect</b>, and <b>Excellence</b> as these values guide our everyday actions with patients, customers, and one another.</p>
<p>
In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include:</p>
<ul>
<li>Instill Trust and Value Differences</li>
<li>Patient and Community Focus and Collaborate</li>
</ul><h2 class="jobSectionHeader"><b>RESPONSIBILITIES</b></h2>
<ul><li>Utilizes expert knowledge to analyze and interpret applicable regulations (federal and local laws, guidance, ICH-GCP, standards for accreditation, etc.), align, amend and enforce institutional policies and procedures, and protect human research participants.</li>
<li>Provides current and accurate compliance information and resources to the research community.</li>
<li>Communicates regulatory changes, updates procedures according to best practices, and acts as a resource to colleagues and researchers in the area of research compliance.</li>
<li>Evaluates compliance by planning and performing monitoring for investigator-initiated trials, in order to assess risk and ensure adherence to institutional policies and procedures, local and federal regulations (i.e., OHRP, FDA, etc.) and Good Clinical Practices (ICH-GCP).</li>
<li>Develops and maintains quality assessment standards, tools, policies, and procedures needed to perform internal assessments of the conduct of clinical research at the institution.</li>
<li>Documents detailed compliance findings and recommendations (with regulatory citations) in a timely manner that allows for proper review and assessment of the risks identified (including root cause analysis) and the conclusions drawn.</li>
<li>Exercises appropriate judgment in evaluating audit findings, develops corrective and preventive action (CAPA) plans, provides targeted education and resources for resolution in a collegial and educational manner.</li>
<li>Assists research teams in resolving issues and ensures responses and corrective and preventative action plans are implemented in a timely manner.</li>
<li>Collects data on audit findings, prepares comprehensive reports (QA metrics), and analyzes trends to identify process failures and direct quality improvement and training initiatives.</li>
<li>Presents data, trends, and risk assessments to Brown University Health Office of Cancer Research (LOCR) Quality Committee.</li>
<li>Works with LOCR Leadership to develop and deliver educational offerings driven by audit findings (e.g., forms and checklists, educational training, regulatory advice/consultation, etc.) for investigators, research staff, and other members of the Brown University Health Cancer Institute to promote the responsible conduct of research and assists with site or study-specific self-assessments.</li>
<li>Investigates compliance breaches, gathers relevant information, assesses impact, determines steps to mitigate risk, and reports findings.</li>
<li>Assists in the management of external audits by regulatory agencies or business partners.</li>
<li>Provides information and services to help research with FDA inspection readiness.</li>
<li>Other job functions as assigned.</li>
</ul><h2 class="jobSectionHeader"><b>MINIMUM QUALIFICATIONS</b></h2>
<p><b>
EDUCATION:</b></p>
<ul>
<li>Bachelor's degree in a healthcare-related field required. Nursing degree preferred.</li>
<li>Certification or eligibility to sit for Certification Exam in relevant area (i.e., Certified IRB Professional (PRIM&amp;R), Certified Clinical Research Professional (SOCRA), Certified Clinical Research Coordinator or Associate (ACRP), Society for Quality Assurance and the American Society for Quality, etc.).</li>
<li>Detailed knowledge of federal, state, and local regulations and an in-depth understanding of ethical principles regarding the protection of human subjects in research.</li>
<li>Working knowledge of local and federal regulations for human subjects research (ICH-GCP, OHRP, FDA regulations).</li>
</ul>
<p><b>EXPERIENCE:</b></p>
<ul>
<li>A minimum of 5 years substantive experience with Phase I through Phase III trials at the Clinical Research Coordinator or Research Nurse. Training or leadership experience preferred.</li>
<li>Excellent customer service, project management, and process improvement skills. Ability to take initiative, prioritize tasks to meet deadlines, produce results, and cope with the inherent pressures.</li>
<li>Excellent organizational and analytical skills: ability to apply presentation and training skills.</li>
<li>Ability to perform multiple tasks with a high level of accuracy and attention to detail.</li>
<li>Proficient computer skills (Excel, Word, Outlook, Access, PowerPoint; electronic medical record (EPIC)).</li>
</ul>
<p><b>SUPERVISORY RESPONSIBILITY:</b></p>
<p>
May supervise 5-10 FTEs.</p>
<h2 class="jobSectionHeader"><b>
PAY RANGE</b></h2>
<p>
$71,136.00 - $117,353.60</p>
<h2 class="jobSectionHeader"><b>
LOCATION</b></h2>
<p>
Rhode Island Hospital - 593 Eddy Street Providence, Rhode Island 02903</p>
<h2 class="jobSectionHeader"><b>
WORK TYPE</b></h2>
<p>
Mon-Thur 7:00 am - 5:30 pm</p>
<h2 class="jobSectionHeader"><b>
WORK SHIFT</b></h2>
<p>
Day</p>
<h2 class="jobSectionHeader"><b>
DAILY HOURS</b></h2>
<p>
10 hours</p>
<h2 class="jobSectionHeader"><b>
DRIVING REQUIRED</b></h2>
<p>
No</p>
<p><i>
Brown University Health is committed to providing equal employment opportunities and maintaining a work environment free from all forms of unlawful discrimination and harassment.</i></p></div></div>

Clinical Research Quality Assurance & Improvement Specialist

MCMC

<div><div><div><b>Ready for a Rewarding Career that Fits Your Lifestyle?</b>
</div></div><p></p><div><div>Imagine a job where you can keep your <b>clinical skills sharp</b>, tackle exciting challenges, AND work from the comfort of your own home. Sounds like the perfect mix, right?</div></div><p>
</p><p></p><div><div><b>MES</b> is looking for a <b>self-driven, high-performing Registered Nurse (RN) or Licensed Vocational Nurse (LVN)</b> to join our dynamic team as a <b>Clinical Quality Assurance Coordinator</b>. In this role, you&rsquo;ll ensure our <b>Peer Review case reports</b> are nothing short of exceptional&mdash;delivering top-notch quality and integrity, all while staying fully aligned with <b>client agreements</b>, <b>regulatory standards</b>, and <b>state and federal mandates</b>.</div></div><p>
</p><div><div>The position is <b>100% remote</b> with a schedule of<b> </b><b>Monday through Friday:</b></div></div><ul><li><div><b>
three days: 12-8:30PM EST
</b></div></li><li><div><b>two days: 8-4:30PM EST</b></div></li></ul><p>
</p><ul><li><div>Performs quality assurance review of peer review reports, correspondences, addendums or supplemental reviews.</div></li><li><div>
Ensures clear, concise, evidence-based rationales have been provided in support of all recommendations and/or determinations.</div></li><li><div>
Ensures that all client instructions and specifications have been followed and that all questions have been addressed.</div></li><li><div>
Ensures each review is supported by clinical citations and references when applicable and verifies that all references cited are current and obtained from reputable medical journals and/or publications.</div></li><li><div>
Ensures the content, format, and professional appearance of the reports are of the highest quality and in compliance with company standards.</div></li><li><div>
Ensure that the appropriate board specialty has reviewed the case in compliance with client specifications and/or state mandates and is documented accurately on the case report.</div></li><li><div>
Verifies that the peer reviewer has attested to only the fact(s) and that no evidence of reviewer conflict of interest exists.</div></li><li><div>
Ensures the provider credentials and signature are adhered to the final report.</div></li><li><div>
Identifies any inconsistencies within the report and contacts the Peer Reviewer to obtain clarification, modification or correction as needed.</div></li><li><div>
Assists in resolution of customer complaints and quality assurance issues as needed.</div></li><li><div>
Ensures all federal ERISA and/or state mandates are adhered to at all times.</div></li><li><div>
Provides insight and direction to management on consultant quality, availability and compliance with all company policies and procedures and client specifications.</div></li><li><div>
Promote effective and efficient utilization of company resources.</div></li><li><div>
Participate in various educational and or training activities as required.</div></li><li><div>
Perform other duties as assigned.</div></li></ul><p>
</p><div></div><div><div>If you&rsquo;re ready to make a real impact in healthcare, all while enjoying the flexibility of working remotely, we want to hear from you!
</div></div><p></p><ul><li><div>Active RN/LVN nursing license required.</div></li><li><div>
Must be a graduate of an accredited nursing program or related medical experience; bachelor's degree preferred.</div></li><li><div>
A minimum of two years clinical or related field experience; or equivalent combination of education and experience.
</div></li><li><div>Must have strong knowledge of medical terminology, anatomy and physiology, medications and laboratory values.</div></li><li><div>
Must be able to add, subtract, multiply, and divide in all units of measure, using whole numbers and decimals; Ability to compute rates and percentages.</div></li><li><div>
Must be a qualified typist with a minimum of 40 W.P.M</div></li><li><div>
Must be able to operate a general computer, fax, copier, scanner, and telephone.</div></li><li><div>
Must be knowledgeable of multiple software programs, including but not limited to Microsoft Word, Outlook, Excel, and the Internet.</div></li><li><div>
Must possess excellent skills in English usage, grammar, punctuation and style.</div></li><li><div>
Ability to follow instructions and respond to upper managements&rsquo; directions accurately.</div></li><li><div>
Demonstrates accuracy and thoroughness. Looks for ways to improve and promote quality and monitors own work to ensure quality is met.</div></li><li><div>
Must demonstrate exceptional communication skills by conveying necessary information accurately, listening effectively and asking questions where clarification is needed.</div></li><li><div>
Must be able to work independently, prioritize work activities and use time efficiently.</div></li><li><div>
Must be able to maintain confidentiality.</div></li></ul><p>
</p><p></p><div><div><b>MES Solutions</b> is a premier provider of independent medical examination and peer review services to the insurance, corporate, legal, and government sectors. Members of our credentialed medical panel conduct physical examinations or medical record reviews, delivering reports that assist clients in the resolution of automotive, disability, liability, and workers' compensation claims. MES has been providing services nationally since 1978 in accordance with the industry's highest standards of operating excellence and regulatory compliance.</div></div><p>
</p><p></p><div><div>Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected category under applicable federal, state, and local laws.</div></div><div><div><b>
Equal Opportunity Employer - Minorities/Females/Disabled/Veterans</b></div></div><div><div><b><i>
MES offers a fast-paced team atmosphere with competitive benefits (medical, vision, dental), paid time off, and 401k.</i></b></div></div></div>

Clinical Quality Assurance Coordinator

Arizona Arthritis and Rheumatology

<div>Description:
<p>
Our providers work together to keep patients healthy and are recognized for excellence in medicine and for being pioneers in new treatments, ably supported by our Research department.</p><p>
We are an equal employment opportunity employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability.</p><p>
Our vision is to provide the best Rheumatology care, anywhere and, to balance sustainable operation with the highest possible level of patient care.</p><p>
We are a seeking an ambitious, friendly, positive, and compassionate Clinical Research Systems Quality Specialist to join our team.</p><p>
Under minimal supervision, the System Quality Specialist (SQS) owns and improves the quality, integrity, and compliance readiness of clinical research electronic systems (e.g., CTMS, eSource/EDC, eRegulatory, M365, and related reporting tools). The SQS defines data quality standards and controls, manages system change control and quality validation/testing, monitors system performance using dashboards and metrics, and maintains audit-ready documentation (SOPs, training records, configuration and validation evidence). The SQS partners with cross-functional stakeholders to implement study builds and amendments, communicate system updates, ensure appropriate access controls, and drive corrective/preventive actions to prevent recurring system and data quality issues.</p><p>
RESPONSIBILITIES</p><ul><li>
Establish and maintain system quality management practices for clinical research platforms (e.g., CTMS, eSource/EDC, eRegulatory, M365), including documentation standards, validation evidence, and release readiness criteria</li><li>
Ensure architecture and data inputs for systems below continuously meet or exceed minimum quality standards</li><li>
Clinical Conductor CTMS</li><li>
Advarra eSource +EDC</li><li>
Veeva SiteVault eReg</li><li>
Monday Work Management</li><li>
SharePoint Pages &amp; Training Workflows</li><li>
Power Query/BI Dashboards</li><li>
in the CTMS system for both protocol and financial compliance</li><li>
Review, finalize and approve esource and CTMs builds for all new studies and amendments</li><li>
Ensure all systems are updated when amendments occur and announce changes to stakeholders</li><li>
Perform routine quality inspections of system data inputs for compliance with internal policy, standard operating procedures, ICH-GCP Standards, local and FDA regulations</li><li>
Ensure all system quality controls are in place prior to release (e.g., procedural instructions, conditional/required fields, data constraints, standardized build templates, and controlled vocabularies) to reduce downstream queries and protocol deviations</li><li>
Perform root cause analysis for recurring system/data quality issues; lead remediation plans to prevent reoccurrence (process, training, configuration, or automation changes)</li><li>
Maintain dashboards/metrics (e.g., query rates, missing/late data, build defect rates, timeliness KPIs) and drive corrective/preventive actions</li></ul><p>
Learn more about AARA on our website at http://azarthritis.com</p>
Requirements:
<p>
QUALIFICATIONS</p><ul><li>
Bachelor&rsquo;s Degree or equivalent</li><li>
2 years clinical research coordinator experience</li><li>
Rheumatology Experience Preferred</li><li>
Must be able to sit for long periods of time</li><li>
Demonstrated experience applying quality controls to electronic clinical research systems to ensure accurate, complete, and timely data</li><li>
Expensive working knowledge of relevant electronic systems, including eSource, CTMS, eReg, and Microsoft 365</li><li>
Strong understanding of good clinical practice, FDA regulations, &amp; data integrity principles (e.g., ALCOA/C+) with an ability to translate them into system configuration, workflows, and user guidance</li><li>
Proficiency building and interpreting operational quality metrics and dashboards</li></ul></div>

Clinical Research Systems Quality Specialist

<div><p><b>Calling All LPNs and RNs!</b>
</p><p></p><p>Are you an LPN's and RN's looking for an exciting new opportunity? <b>MCMC</b> is on the hunt for a talented <b>Clinical Quality Assurance Coordinator</b> to join our growing team! In this role, you&rsquo;ll dive into medical records, pulling out key details and crafting detailed narrative summaries. Your keen eye for detail will make you an invaluable part of our quality assurance process.</p><p>
</p><div><b>Why You&rsquo;ll Love This Role:</b><br>
<b>-100% Remote</b> &ndash; Work from where you're most comfortable - home!<br>
<ul><li><b>Flexible Hours</b> &ndash; Monday-Friday. Start your day between 11:30am EST, and end at 8:00pm EST.</li></ul></div><p>
At MCMC, we&rsquo;re an <b>employee-first</b> company offering fantastic <b>benefits</b> and incredible <b>growth opportunities</b>. If you&rsquo;re ready to take the next step in your career with a team that values your expertise, we want to hear from you!</p><p>
</p><p>Don&rsquo;t wait&mdash;apply today and join us on this exciting journey!
</p><p></p><p><b>MINIMUM REQUIRED QUALIFICATIONS</b></p><p><b>
Education and/or Experience
</b></p><p>High school diploma or equivalent required. A minimum of two years clinical or related field experience; or equivalent combination of education and experience preferred. Knowledge of the insurance industry, preferably claims management relative to one or more of the following categories: workers' compensation, no-fault, liability, or disability preferred.</p><p><b>
Certificates, Licenses, Registrations
</b></p><p>LPN/LVN/RN may be required based on business needs.</p><p>
</p><p><b>ESSENTIAL COMPETENCIES
</b></p><p><b>QUALIFICATIONS
</b></p><ul><li>Must have strong knowledge of medical terminology, anatomy and physiology, medications and laboratory values.</li><li>
Must be a qualified typist with a minimum of 40 W.P.M</li><li>
Must have a full understanding of HIPAA regulations and compliance.</li><li>
Must be able to operate a general computer, fax, copier, scanner, and telephone.</li><li>
Must be knowledgeable of multiple software programs, including but not limited to Microsoft Word, Outlook, Excel, and the Internet.</li><li>
Must demonstrate exceptional communication skills.</li><li>
Ability to follow instructions and respond to upper managements&rsquo; directions accurately.</li><li>
Must demonstrate accuracy and thoroughness. Look for ways to improve and promote quality and monitors own work to ensure quality is met.</li><li>
Must be able to work independently, prioritize work activities and use time efficiently.</li><li>
Must be able to maintain confidentiality.</li><li>
Must be able to demonstrate and promote a positive team -oriented environment.</li><li>
Must be able to stay focused and concentrate under normal or heavy distractions.</li><li>
Must be able to work well under pressure and or stressful conditions.</li><li>
Must possess the ability to manage change, delays, or unexpected events appropriately.</li><li>
Ability to follow all company policies and procedures in effect at time of hire and as they may change or be added from time to time.</li></ul><p><b>
LANGUAGE/COMMUNICATION SKILLS
</b></p><ul><li>Ability to read, analyze and interpret common correspondence, medical records, and legal contracts and documents.
</li><li>Ability to write clearly and informatively to all required audiences and edit own work for appropriate spelling and grammar.</li><li>
Ability to respond appropriately and professionally to all inquiries or complaints from customers, physicians, regulatory agencies, and/or members of the business community.
</li><li>Ability to effectively present information one-on-one or in small groups.</li></ul><p><b>
PHYSICAL DEMANDS
</b></p><p>The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.</p><p>
This position generally consists of:</p><ul><li>
Ability to work at a desk or similar office-type furnishings up to 8 hours a day or longer as required by business needs.</li><li>
Ability to operate a computer up to 4 hours at a time.</li><li>
Ability to travel to different floors of the office or other locations.</li><li>
Ability to move throughout the office.
</li><li>Occasionally lifting and/or carrying up to 10 lbs.</li><li>
Occasionally pushing/pulling up to 10 lbs.</li><li>
Occasionally subject to bending, squatting or twisting.</li></ul><p><b>
WORK ENVIRONMENT
</b></p><p>The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.</p><ul><li>
Extended hours are occasionally required beyond the regular eight (8) hour work day.</li><li>
The noise level in the work environment is usually moderate.<b>
</b></li></ul><p></p><p>MCMC is an Equal Opportunity Employer and affords equal opportunity to all qualified applicants for all positions without regard to protected veteran status, qualified individuals with disabilities and all individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age or any other status protected under local, state or federal laws.</p><p>
</p><p><b>Equal Opportunity Employer - Minorities/Females/Disabled/Veterans</b></p></div>

Arkana Laboratories

<div><div><p><b>Who we are:</b> At Arkana Laboratories, everyone has an important role to fill. Come join us and be a part of a team dedicated to making life better for those who need it most.</p>
<p>
This place is packed with super-smart people who do their best work together. We work hard every day to advance our understanding of disease and provide world-class care to our patients in hopes of leaving our corner of the world a little better than we found it. While we are committed to improving the lives of thousands of patients, we never lose sight of the realization that they are the reason we get to create change in our field.</p>
<p>
Built on generosity, teamwork, and the freedom to try new things, we take great pride in our work. Great ideas come from everywhere in this company and we celebrate each success and failure for the opportunity it gives us to keep reaching. For more than twenty years after our founder, Dr. Patrick Walker, wrote his goals on the back of a napkin, our people, culture, and values have remained strong.</p></div><p><b>
About the position: </b>As the Clinical Data Quality Specialist, you will ensure the integrity and clinical validity of laboratory data while supporting AI/ML initiatives through expert annotation and data curation. This role represents a fundamental transformation from traditional documentation functions to modern data operations, requiring individuals who embrace change, demonstrate initiative, and are committed to continuous learning. This position bridges clinical knowledge and data science, transforming healthcare data into high-quality assets that power analytics, research, and artificial intelligence applications. Success requires adaptability, technical curiosity, and the ability to work independently in an evolving environment.</p>
<p><b>
What you'll do:</b></p>
<p><b>
Data quality and validation</b></p>
<ul>
<li><p>Review and audit laboratory data for accuracy, completeness, and clinical validity</p>
</li>
<li><p>Identify and resolve data inconsistencies and quality issues</p>
</li>
<li><p>Validate automated processes and ensure alignment with quality standards</p>
</li>
<li><p>Support development of data quality metrics and tracking tools</p>
</li>
</ul><p><b>Clinical data annotation and curation</b></p>
<ul>
<li><p>Annotate and categorize clinical data to support machine learning models</p>
</li>
<li><p>Apply medical terminology and clinical knowledge to ensure accuracy</p>
</li>
<li><p>Maintain consistency and meet established accuracy standards</p>
</li>
<li><p>Contribute to data dictionaries and documentation standards</p>
</li>
</ul><p><b>Automation and process improvement</b></p>
<ul>
<li><p>Monitor automated workflows and identify opportunities for improvement</p>
</li>
<li><p>Support testing and validation of new systems and tools</p>
</li>
<li><p>Recommend enhancements to improve efficiency and data quality</p>
</li>
</ul><p><b>Collaboration and communication</b></p>
<ul>
<li><p>Partner with data science, IT, and laboratory teams on cross-functional projects</p>
</li>
<li><p>Provide clinical context to support technical initiatives</p>
</li>
<li><p>Participate in team knowledge sharing and process development</p>
</li>
</ul><p><b>Continuous development</b></p>
<ul>
<li><p>Complete training in data quality, systems, and clinical informatics</p>
</li>
<li><p>Stay current with trends in healthcare data and technology</p>
</li>
<li><p>Take initiative in learning new tools and expanding skill sets</p>
</li>
<li><p>Perform other duties as assigned</p>
</li>
</ul><p><b>What you bring:</b></p>
<ul>
<li><p>Strong attention to detail and analytical thinking</p>
</li>
<li><p>Ability to work independently and take initiative</p>
</li>
<li><p>Comfort working in a changing and evolving environment</p>
</li>
<li><p>Strong communication and collaboration skills</p>
</li>
<li><p>Curiosity and interest in data, technology, and process improvement</p>
</li>
</ul><p><b>Qualifications</b></p>
<ul>
<li><p>High school diploma or GED required; associate degree or higher preferred</p>
</li>
<li><p>Two or more years of experience in healthcare documentation, medical records, laboratory operations, or a related field</p>
</li>
<li><p>Experience with EHR, LIS, or similar systems</p>
</li>
<li><p>Proficiency in Microsoft Excel and general computer applications</p>
</li>
<li><p>Knowledge of medical terminology and healthcare workflows</p>
</li>
<li><p>Understanding of HIPAA and data confidentiality requirements</p>
</li>
</ul><p><b>Preferred qualifications</b></p>
<ul>
<li><p>Certification such as RHIT, RHIA, or CCA, or willingness to pursue</p>
</li>
<li><p>Exposure to data analysis tools, SQL, or reporting platforms</p>
</li>
<li><p>Experience with quality audits or data validation processes</p>
</li>
</ul><p><b>Schedule: Monday-Friday 8am-5pm</b></p><div><p><b>
What we offer:</b> We know that health is more than doctor visits and life is more than work. We work hard at Arkana but in turn provide competitive salaries and generous benefit offerings.</p>
<p>
Specifically, we offer the following benefits to full-time employees:</p>
<ul>
<li>Competitive salary</li>
<li>Generous paid time off and Paid Holidays</li>
<li>Minimal cost health insurance for you and affordable options for your family</li>
<li>401(k) with immediate eligibility and match</li>
<li>Company-paid life insurance</li>
<li>Company-paid long term disability coverage</li>
<li>Affordable vision and dental plans</li>
<li>Flexible Spending Account or Health Savings Account availability</li>
<li>Wellness plan and complimentary yoga classes</li>
<li>Monthly in-office massages and employer-sponsored lunches</li>
</ul>
<p>Please see Careers for further information.</p></div></div>

Clinical Data Quality Specialist

Denali Health Plant City

<p>About Denali Health</p><p>Denali Health is an Independent Research Organization conducting Phase I&ndash;IV clinical trials across psychiatry, neurology, wound care, vaccines, and pediatrics. We operate dedicated research sites in Atlanta and Plant City and partner with leading sponsors and CROs to deliver clean, audit-ready data on every study.</p><p>The Role</p><p>We are hiring a <b>Central Quality Assurance &amp; Audit Prep Lead</b> to own inspection readiness across our entire portfolio. This is not a paper-pushing QA role. You will be the person who finds the issue before the CRA does, before the sponsor auditor does, and long before an FDA inspector ever walks through the door.</p><p>You will sit horizontally across both sites and every active protocol, continuously verifying that our source data, regulatory documentation, and sponsor system entries (EDC, IRT/IWRS, ePRO, central lab portals, imaging portals, safety reporting platforms) are complete, accurate, and reconciled at all times.</p><p>What You'll Own</p><ul><li><b>Source verification in CRIO</b> &mdash; ALCOA-C review of every active subject's eSource on a defined cadence; flag and drive resolution of incomplete, unsigned, or inconsistent documentation.</li><li><b>Regulatory binder integrity</b> &mdash; Continuous audit of eReg: 1572s, CVs, licenses, training, financial disclosures, IRB approvals and continuing reviews, protocol signature pages, delegation logs, lab certifications.</li><li><b>Sponsor system reconciliation</b> &mdash; Cross-check CRIO source against EDC, IRT/IWRS dispensing records, ePRO, central lab data, and any other sponsor-mandated portal. Catch mismatches in vitals, dosing, AEs, ConMeds, and lab values before they become findings.</li><li><b>AE/SAE traceability</b> &mdash; Verify every AE in source appears in EDC, every SAE was reported within sponsor timelines with documentation, and all follow-ups are closed.</li><li><b>Protocol deviation oversight</b> &mdash; Maintain the single source of truth for PDs across studies; ensure proper categorization, reporting, and CAPA closure.</li><li><b>IP accountability</b> &mdash; Reconcile dispensing, returns, temperature excursions, and destruction against IRT and EDC records.</li><li><b>Query aging and trend analysis</b> &mdash; Track open queries, root-cause recurring patterns, and partner with site leadership on retraining when needed.</li><li><b>Pre- and post-monitoring visit prep</b> &mdash; Ready the site before CRA arrival; drive follow-up letter action items to closure within sponsor-required windows.</li><li><b>Internal mock audits</b> &mdash; Run BIMO-style inspections per study, produce findings reports, assign and verify CAPAs.</li><li><b>Quality dashboard for leadership</b> &mdash; Monthly reporting on SDV pass rate, query aging, regulatory expiry calendar, deviation trends, and findings by site/PI/CRC.</li></ul><p>What We're Looking For</p><ul><li>3+ years in clinical research with hands-on experience in QA, monitoring, or senior CRC/regulatory work</li><li>Deep working knowledge of ICH-GCP, 21 CFR Parts 11/50/54/56/312, and ALCOA-C principles</li><li>Proficiency in <b>CRIO</b> (eSource and eReg) is strongly preferred</li><li>Comfort working across multiple sponsor EDC platforms (Medidata Rave, Veeva, Oracle, etc.) and IRT/IWRS systems</li><li>A pattern-recognition mindset &mdash; you spot the anomaly in a 200-row export and you know which finding kills a site at audit</li><li>Strong written communication; you can document a finding and a CAPA cleanly</li><li>Self-directed and organized; this role drives its own cadence across multiple studies</li></ul><p>Why This Role</p><p>You will report directly to the VP of Clinical Operations and have visibility into every study we run. The work you do directly determines whether sponsors return for the next study. We measure this role on outcomes &mdash; clean audits, fast query resolution, zero critical findings &mdash; not on hours logged.</p><p>How to Apply</p><p>We want to hear and see you, not just read your resume.</p><p><b>Send a 2&ndash;4 minute video introduction to</b> talent@denali-health.com <b>along with your resume.</b></p><p>In the video, please cover:</p><ul><li>Your background in clinical research and what drew you to QA / audit readiness specifically</li><li>A concrete example of a finding you caught (or wish someone had caught) &mdash; what was it, how did you find it, and what was the outcome?</li><li>Which EDC, IRT, and eSource/eReg systems you've worked in</li><li>What your first 30 days in this role would look like</li></ul><p>Subject line: <b>Central QA &amp; Audit Prep Lead &mdash; [Your Name]</b></p><p>We review every video personally. Applications without a video will not be prioritized.</p><p><i>Denali Health is an equal opportunity employer. We are committed to building a team that reflects the diversity of the patients and communities we serve.</i></p><p>Work Location: Remote</p>

Clinical Research Quality Assurance and Audit Prep Lead

Metro Vein Centers

<div><div><p>Metro Vein Centers is a rapidly growing healthcare practice specializing in state-of-the-art vein treatments. Our board-certified physicians and expert staff are on a mission to improve people's quality of life by relieving the painful, yet highly treatable symptoms of vein disease&mdash;such as varicose veins and heavy, aching legs.</p>
<p>
With over <b>60 clinics across 7 states</b>, and still growing, we're building the future of vein care&mdash;delivering compassionate, results-driven care in a modern, patient-first environment.</p>
<p>
We proudly maintain a <b>Net Promoter Score (NPS) of 93</b>, the highest patient satisfaction in the industry.</p></div><p>
Metro Vein Centers (MVC) is seeking a <b>Clinical Quality Manager</b> to spearhead the growth and optimization of our national clinical performance. Reporting to the <b>Director of Clinical Documentation &amp; Coding</b>, this remote leader will serve as the technical expert for clinical quality, value-based care, and clinical documentation improvement initiatives. You will be responsible for bridging the gap between clinical data and operational excellence, ensuring MVC maximizes its quality scores and reimbursement potential through rigorous analysis and change management.</p>
<h2 class="jobSectionHeader"><b>
What You Will Do</b></h2>
<ul><li><b>Clinical Auditing:</b> Conduct deep-dive reviews of current documentation and workflows within the electronic health record (EHR) to identify gaps in quality and compliance.</li>
<li><b>Provider Education:</b> Assist with clinical documentation training and feedback sessions for providers to ensure evidence-based standards, documentation, and coding accuracy requirements are met.</li>
<li><b>Quality Performance Monitoring:</b> Identify all qualifying opportunities, and Develop, Implement, and Monitor MVC's pay for performance/value-based incentive programs to ensure alignment with specific payer contracts.</li>
<li><b>Data Reporting:</b> Develop and analyze new and existing data reports to communicate performance trends and &quot;red flags&quot; to leadership teams.</li>
<li><b>Process Engineering:</b> Identify opportunities for automation and software enhancements to streamline quality reporting and documentation auditing &amp; coding workflows as the practice grows.</li>
<li><b>Clinical Quality Leader:</b> Establish a unified clinical roadmap that aligns national clinical guidance with regulatory &amp; payer requirements and organizational strategy. Ensures clinical operations are within regulation and meet the highest level of quality.</li>
<li><b>Stakeholder Liaison:</b> Build partnerships across IT, Credentialing, and Clinical Operations to ensure clinical guidance meets both business and patient needs.</li>
</ul><h2 class="jobSectionHeader"><b>Minimum Qualifications</b></h2>
<ul><li><b>Expertise:</b> In-depth knowledge and experience with Healthcare Effectiveness Data and Information Sets (HEDIS), CMS Quality Payment Programs (QPP), Advanced Alternative Payment Models (APM), Merit-based Payment Systems (MIPS), and payer specific Quality Initiative Value-Based Reimbursement programs.</li>
<li><b>Technical Literacy:</b> Ability to navigate Electronic Medical Records (EMR), data reporting (Tableau), and Google Sheets/Microsoft Office systems efficiently.</li>
<li><b>Experience:</b> 5+ years of physician revenue cycle experience with a focus on clinical quality standards at a national level.</li>
<li><b>Leadership:</b> 5+ years of experience leading clinical quality efforts and change management in a fast-growth environment.</li>
<li><b>Education:</b> Associate's degree or higher in Business, Healthcare Administration/Management, HIM, Informatics, or associated track..</li>
</ul><h2 class="jobSectionHeader"><b>Preferred Qualifications</b></h2>
<ul><li><b>Certifications:</b> CPHQ or CHQM highly preferred. Open to other relatable certifications.</li>
<li><b>Coding Expertise:</b> CPC, CPMA, CCS, RHIT, or CDIP certifications are a significant plus.</li>
<li><b>Systems:</b> Previous experience with <b>Athena Practice (GE Centricity) EMR</b>.</li>
<li><b>Specialty:</b> Experience within vascular or vein-specific clinical environments.</li>
</ul>
<p><b>Clinical Background:</b> Experience as an LPN, RN, NP/PA, or FMG/IMG.</p>
<h3 class="jobSectionHeader"><b>
Benefits to Support Your Wellbeing &amp; Lifestyle</b></h3>
<p>
Full-time team members at Metro Vein Centers are eligible for:</p>
<ul>
<li>Medical, Dental, and Vision Insurance</li>
<li>401(k) with Company Match</li>
<li>Paid Time Off (PTO) + Paid Company Holidays</li>
<li>Company-Paid Life Insurance</li>
<li>Short-Term Disability Insurance</li>
<li>Employee Assistance Program (EAP)</li>
<li>Career Growth &amp; Development Opportunities</li>
</ul>
<p>#LI-Remote</p><div><p><b>
The Metro Vein Centers Difference</b></p>
<p><b>
Healthy legs. Happier lives.</b><br>
At Metro Vein Centers, we believe exceptional care begins with an exceptional experience. Our mission is to make vein care approachable, empowering, and connected to overall well-being. From the first conversation to the final follow-up, every patient interaction reflects our commitment to compassion, expertise, and trust.</p>
<p><b>
A team united by purpose.</b><br>
Our values guide everything we do:</p>
<ul>
<li><b>Patients First, Always</b> &ndash; Every interaction should make our patients feel valued, heard, and cared for.</li>
<li><b>Stronger Together</b> &ndash; Teamwork and collaboration drive our success. We lift each other up to deliver the best for our patients.</li>
<li><b>A Can-Do Spirit</b> &ndash; We meet every challenge with positivity, flexibility, and problem-solving energy.</li>
<li><b>Results That Make a Difference</b> &ndash; We're driven to improve lives through meaningful, measurable outcomes.</li>
<li><b>Commitment to Growth</b> &ndash; We invest in our people, fostering advancement and professional development at every level.</li>
</ul>
<p><b>Metro Vein Centers is an Equal Opportunity Employer.</b><br>
We're committed to creating a workplace where everyone feels seen, heard, and supported. We do not discriminate based on race, color, religion, sex, national origin, age, disability, genetics, gender identity or expression, sexual orientation, veteran status, or any other protected status in accordance with applicable federal, state, and local laws. This policy applies to all aspects of employment, including recruitment, hiring, promotion, compensation, benefits, and termination.</p>
<p><b>
Legal &amp; Compliance Notice:</b><br>
Metro Vein Centers complies with all applicable federal, state, and local employment laws, including those related to nondiscrimination, equal opportunity, and pay transparency. Where specific disclosures or postings are required by law, we provide this information as part of our hiring process or upon request.</p>
<p><b>
Your privacy matters.</b><br>
To learn more about how we collect, use, and protect your information, please review our privacy policy here.</p></div></div>

Clinical Quality Manager

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