Jennifer Matson Hunter
Director of Research Operations at Mary Crowley Cancer Research- Claim this Profile
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Bio
Credentials
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Certified Clinical Research Professional (CCRP)
Society of Clinical Research Associates (SOCRA)Jan, 2022- Nov, 2024
Experience
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Mary Crowley Cancer Research
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United States
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Hospitals and Health Care
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1 - 100 Employee
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Director of Research Operations
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Aug 2021 - Present
Oversee research operations including study development, regulatory affairs, clinical trial management, data management, medical records, & quality assurance.• Restructured research operations and implemented a team structure to improve overall organizational efficiency, role clarification, and professional advancement• Developed a diversity, equity, and inclusion committee • Created a technology task force that deployed MS Teams and spearheads initiatives• Established a recurring trial portfolio review and strategic trial enrollment review • Designed an acuity system & workload queue for workload management & oversight• Drafted & Instituted a working from home guidance• Oversee SOP refinement and harmonization initiative• Increased informed consent drafters by 400% through continuing education Show less
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Quality Assurance Manager and Process Improvement Manager
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Feb 2019 - Aug 2021
In collaboration with research and clinic operations, ensure site compliance with internal benchmarks, protocol requirements, ICH GCP guidelines, and federal regulations. Responsible for routine assessment of overall site quality assurance and implementation of process improvements.• Spearheaded implementation of clinical trial management system (CTMS) for 90+ end users, migration of 1000+ patients, 120+ studies. Ongoing oversight of CTMS vendor & digitization deliverables• Expanded quality improvement and initiative committee. Produced recurring quality assurance reports & communicated results.• Led audit preparation, conduct, and corrective and preventative action plans• Supervised task forces for quality initiatives including: SAE process & timelines; delegation of authority; industry shifts; electronic signature implementation & utilization; finance workflows; IND safety report electronic investigator review• Developed quality and compliance scorecard for high-level overview• Reduced the # of delegation of responsibility profiles by ~67%• Established an amendment decision tree and new risk tracker Show less
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Implementation Project Manager
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Feb 2018 - Feb 2019
Contributed to specific project implementation and served as quality committee member• Measured specific key performance benchmark indicators and communicated results• Created tools for process improvement initiatives including an informed consent checklist guideline and internal SAE internal communication form• Implemented data pilot that reduced external query backlog average by 78% and reduced data entry timeliness by 59%• Evaluated development process for a 22% reduction of steps• Created IND report workflow to bill for IND reports• Performed financial audits Show less
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Data and Compliance Coordinator
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Jul 2015 - Mar 2018
Responsible for data quality and site compliance of I-I trials in addition to generating reports for specific quality measures and communicating results• Developed study monitoring plans for trials where Mary Crowley holds the IND• Monitored investigator-initiated trials with risk-based monitoring approach• Communicated findings to investigator/applicable site staff. Aided in mitigating identified risks and developing/managing action plans as needed• Assisted in providing details required for FDA annual reports • Participated in internal MQA audit preparation • Created and presented reports related to research departmental productivity, data analysis, data analysis parameters, and other high-level areas of risk• Attended quarterly quality risk management meetings and participated in discussions regarding observations, successes, and improvement opportunities• Helped create and manage central site and satellite follow-up tracker• Performed routine internal quality check of the following items: IRB Meeting Minutes, informed consent form documents, training and delegation records Show less
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Align CRO
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Dallas-Fort Worth Metroplex
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Clinical Trial Monitor
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Mar 2016 - Jan 2018
Conducted IMVs for Phase II trial to review compliance with GCP & 21 CFR Part 312. • Monitored the accuracy and completeness of reported data against source • Reviewed the trial master file to verify applicable essential documents are present • Performed drug accountability reconciliation for proper receipt, storage, & use • Communicated study observations and noncompliance issues to investigator & applicable site staff; ensure actions plans appropriate to level of risk are initiated when deemed necessary • Trained new Clinical Research Associates & Trial Monitors Show less
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Mary Crowley Cancer Research
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United States
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Hospitals and Health Care
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1 - 100 Employee
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Data Coordinator
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Mar 2013 - Jul 2014
Performed DC functions on trials with high accrual and acuity • Trained and mentored new hires on data management processes • Aided in the conception and piloting process improvement initiatives Completed Electronic Data Captures (EDCs) or Case Report Forms (CRFs) • Ensured CRFs were complete, accurate representations of source and available to sponsor • Generated queries to clinical nurses/coordinators and tracked until resolution • Identified and communicated protocol deviations & study-specific trends • Interacted with sponsor representatives to facilitate productive monitoring visits; communicated deadlines, database locks, cohort reviews, global issues, etc. with site staff • Maintained clinical research database in timely fashion Show less
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Education
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Texas A&M University-Commerce
Bachelor of Arts - BA, Organizational Leadership
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