Director of Quality

ELEVATE CLINICAL RESEARCH, INC.•Beach City, TX

9h•Hybrid

About The Position

The Director of Quality is responsible for overseeing quality assurance and quality control activities across Elevate Clinical Research’s clinical research network. This role ensures that clinical trial documentation, source records, regulatory files, and study processes are maintained in accordance with Good Clinical Practice (GCP), FDA regulations, ICH guidelines, sponsor/CRO expectations, company SOPs, and applicable regulatory requirements. This position reports to the Vice President of Operations and supports quality review, inspection readiness, CAPA follow-up, audit preparation, eSource/eRegulatory data review, and continuous process improvement. The Director of Quality will work closely with site teams, Site Directors, Clinical Operations, Regulatory, Training, and other departments to identify quality risks, improve documentation practices, reduce protocol deviations, and strengthen study compliance across all sites.

Requirements

Bachelor’s degree in life sciences, healthcare administration, nursing, clinical research, or a related field required.
Minimum of 5 years of clinical research experience.
Minimum of 2 years of quality assurance, quality control, monitoring, site management, or clinical operations experience.
Strong knowledge of FDA regulations, ICH-GCP guidelines, informed consent requirements, clinical documentation standards, and inspection readiness expectations.
Experience reviewing clinical trial source documentation, regulatory documents, protocol deviations, CAPAs, and audit findings.
Strong understanding of clinical research quality and compliance requirements.
Strong eSource review skills.
Excellent attention to detail and documentation review skills.
Ability to identify documentation gaps, quality trends, root causes, and process issues.
Ability to supervise and support direct reports.
Ability to communicate clearly with investigators, coordinators, site teams, sponsors, CROs, and internal departments.
Strong organizational and prioritization skills.
Ability to manage multiple studies, sites, deadlines, and competing priorities.
Professional judgment and ability to escalate concerns appropriately.
Strong problem-solving and process improvement mindset.
Ability to maintain confidentiality and handle sensitive information appropriately.

Nice To Haves

Experience using an eSource/eRegulatory platform strongly preferred.
Experience working in a multi-site clinical research organization preferred.
Clinical research certification preferred, such as CCRC, CCRP, ACRP-CP, or equivalent.
Prior experience supporting FDA inspections, sponsor audits, or CRO audits.
Experience with an eSource/eRegulatory system, including source review, query review, signatures, visit tracking, and documentation completion.
Experience using dashboards or reporting tools such as Looker, Power BI, or similar platforms.
Experience developing QC workflows, audit tools, SOPs, trackers, and quality metrics.

Responsibilities

Oversee day-to-day quality assurance and quality control activities across assigned sites and studies.
Supervise and support two direct reports within the Quality team.
Ensure quality reviews are completed timely, accurately, and consistently.
Monitor quality trends and escalate significant quality or compliance concerns to the Vice President of Operations.
Support the implementation of quality workflows, quality review tools, and internal reporting processes.
Partner with site teams to promote consistent documentation, protocol compliance, and inspection readiness.
Review source documentation for completeness, accuracy, timeliness, and protocol compliance.
Monitor visit completion, source completion, late entries, missing data, incomplete forms, and overdue documentation.
Review PI, Sub-I, CRC, and staff signatures within the clinical documentation system to ensure proper oversight and timely sign-off.
Track open queries, query aging, response quality, and recurring query trends.
Identify documentation gaps that may impact monitoring visits, audits, sponsor review, or inspection readiness.
Support quality workflows, including pre-monitoring visit review, pre-randomization review, routine source QC, and targeted review of high-risk visits.
Assist in developing quality reports, trackers, dashboards, and metrics for operational review.
Work with Operations and site teams to ensure records are audit-ready and aligned with source documentation expectations.
Support training needs when recurring documentation or workflow issues are identified.
Ensure review findings are communicated clearly and tracked through resolution.
Review and track protocol deviations, quality events, and CAPAs.
Ensure root cause analysis is documented appropriately, and corrective/preventive actions are clearly defined.
Monitor CAPA timelines and follow up on overdue or incomplete action items.
Track recurring deviation trends and escalate repeat issues to the Vice President of Operations.
Support site teams with documentation of quality events, deviations, corrective actions, and preventive strategies.
Assist with the development, revision, and implementation of SOPs, work instructions, QC checklists, and quality tools.
Identify training needs based on clinical documentation system review findings, audit findings, QC trends, protocol deviations, and sponsor feedback.
Partner with Training and Operations teams to support staff education related to GCP, documentation standards, clinical documentation system workflows, informed consent, source review, and inspection readiness.
Recommend process improvements to reduce recurring documentation errors, delayed signatures, query aging, and preventable deviations.
Track and report quality metrics related to eSource/eRegulatory documentation completion, query aging, missing signatures, QC findings, protocol deviations, CAPA completion, and audit readiness.
Assist in developing quality dashboards using Looker and other reporting tools.
Provide routine quality updates to the Vice President of Operations.
Maintain trackers for QC findings, audit findings, CAPAs, protocol deviations, and inspection readiness action items.
Use data to identify risk areas and recommend corrective actions.
Collaborate with Site Directors, CRCs, Investigators, Regulatory, Training, teams as needed to support compliant study execution.
Serve as a quality resource for site staff regarding documentation, source standards, QC expectations, and study readiness.
Support study start-up, activation, monitoring visits, close-out activities, and sponsor/CRO requests as needed.
Escalate significant quality, compliance, patient safety, or operational concerns to the Vice President of Operations in a timely manner.