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senior manager clinical quality assurance resume example with 9 years of experience

Jessica
Claire
resumesample@example.com
(555) 432-1000,
, , 100 Montgomery St. 10th Floor
:
Professional Summary

Experienced Good Clinical Practice Auditor and Senior Manager of Clinical Quality Assurance dedicated to quality, accuracy, and participant safety. Posses unique skillset for conducting and working in Hybrid and Decentralized Clinical Trials. Ready to bring 17 years of related biomedical and clinical research experience to a challenging new role.

Skills
  • Hybrid and Decentralized Clinical Trials Trial Management, Database Entry, Collection, Development, and Auditing
  • Participated in Pre-Conduct study flow plans to identify gaps in feasibility and processes to mitigate before study implementation
  • Regulatory Compliance Assurance and Developing and Executing Internal Clinical Quality Plans following GCP guidelines
  • Hosting Sponsor Audits while relationship building and retention by communicating effectively with multidisciplinary team of physicians, patients, and other team members
  • Corrective actions and preventive action (CAPA) planning and implementation with root cause analysis and trend identifications
  • Writing SOPs, Informed Consents, HIPAA authorizations, and case report forms and carrying out studies using GCP best practices to minimize redundancy and create efficient workflow.
  • Controlled document management in eQMS system
  • Supporting and Managing Audits/Inspections
  • Risk Assessments
Certifications
  • Certificate of Completion, Good Clinical Practice Auditor, Barnett International, completed January 2023
  • Biomedical Research (GCP), July 2023
  • IATA Biospecimen Shipping and Handling July 2023
  • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus), July 2023
Education
Medical University Of South Carolina Charleston, SC Expected in Master of Science : Clinical Research - GPA :
Medical University Of South Carolina Charleston, SC Expected in Masters : Biomedical Research - GPA :
Clark Atlanta University Atlanta, GA, Expected in Bachelor of Science : Biology - GPA :
Work History
Crispr Therapeutics Ag - Senior Manager, Clinical Quality Assurance
San Francisco, CA, 07/2020 - Current
  • Led and participated in client audit preparation, hosting, and follow-up.
  • Conducted pre-conduct study feasibility and processes evaluation workshops to preemptively identify gaps in procedures, resources and deliverable before study implementation.
  • Assisted with qualifying overseas ex-US sites
  • Hosted 49 sponsor/vendor qualification audits in last 18 months in QA
  • Implemented, developed, and refined SOPs governing clinical and quality operations.
  • Conduct and participate in internal audits of Science 37 cGXP Departments (e.g., Clinical Operations, Nursing Solutions, Medical Affairs) and functional group areas and processes.
  • Developed quality assurance plans by conducting gap and risk analyses.
  • Developed and implemented new filing systems to improve organizational efficiency and productivity.
  • Developed proposals and presentations for internal and external audiences.
  • Provided strong leadership to enhance team productivity and morale by enhancing performance monitoring and instituting motivational approaches.
  • Manager, Clinical Quality Assurance (April 2021- August 2022)
  • Executed internal clinical quality audit plans
  • Supported deviation and CAPA investigations and resolution
  • Participated in client audit preparation, hosting, and follow-up, including support of “staging room.”
  • Conduct and participate in internal audits of Science 37 Clinical Operations, Data Management, Investigative Product, and Nursing
  • Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.
  • Clinical Research Coordinator (In-House CRA) (July 2020- April 2021)
  • Functioned as clinical research coordinator and In-House Clinical Research Associate (CRA) for multitude of decentralized clinical research trials
  • Managed 7 satellite sites for diagnostic clinical trial
  • Validated incoming data to check information accuracy and integrity while independently locating and correcting concerns.
  • Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
Radiant Research - Lead Clinical Research Coordinator
Phoenix, AZ, 02/2019 - 07/2020
  • Conducted quality control checks on internal data across seven studies
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Monitored patient safety throughout clinical trials and reported any adverse events.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Participated in initiation visits and investigator meetings, implementing trials per study timelines and budgets.
  • Collected data and followed research protocols, operations manuals, and case report form requirements in variety of electronic databases.
  • Gathered, processed, and shipped lab specimens.
  • Coordinated clinical trials focused on overactive bladder, Vaginal Prolapse, Urinary Microbiome, and Urogynecology disorders.
  • Increased recruitment and attrition in satellite smaller sites by 150%.
Medical University Of South Carolina - Program Coordinator I (Clinical Research Coordinator)
City, STATE, 03/2014 - 02/2019
  • Initiate and maintain accurate and comprehensive documentation as required by FDA, Institutional Review Board, study sponsors, and Good Clinical Practice Guidelines in connection with research trials.
  • Prepares protocols, consent forms, audit forms, study amendments, continuing reviews, recruitment reports, adverse events, and any other information needed by IRB or study sponsor.
  • Manages day-to-day running of three NCI-funded research protocols in Smoking Cessation Tobacco Treatment Program.
  • Managed team of 4 researchers and study database of six studies with aggregate of 800 subjects
  • Program Coordinator I (Jan 2015 - September 2015)
  • Managed day-to-day running of research protocols in Clinical Neuroscience Division and Ralph H. Johnson Veterans Administration Medical Center coordinating 4 cohorts of research participants.
  • Managed data collection of two distinct subject groups and entry functions into VA VINCI systemic database.
  • Performed diagnostic interviews consisting of structured clinical interviews such as Addiction Severity Index (ASI) MINI International Neuropsychiatric Interview, Montreal Cognitive Assessment, Timeline Follow Backs, and other related instruments.
  • Performed Drugs Tests and breathalyzers on research participants.
  • Program Assistant (Clinical Research Assistant) Mar 2014- January 2015
  • Managed two studies
  • Participated in preparation and management of research budgets and monetary disbursements.
  • Educated patients regarding all facets of clinical study participation.
  • Informed patients or caregivers about study aspects and outcomes to be expected.
  • Coded, evaluated or interpreted collected study data.
  • Monitored study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
  • Maintained required records of study activity, including case report forms, drug dispensation records, or regulatory forms.
  • Communicated with laboratories or investigators regarding laboratory findings.
  • Recruited and screened potential research participants.
  • Enrolled and consented pediatric adolescents
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Demonstrated advanced knowledge of federal regulatory compliance guidelines.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Gathered, processed, and shipped lab specimens.
  • Followed informed consent processes and maintained records.
  • Maintained detailed records of test results by entering data and patient information into computer.
  • Implemented care and efficiency improvements to support and enhance office operations.

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Resume Overview

School Attended

  • Medical University Of South Carolina
  • Medical University Of South Carolina
  • Clark Atlanta University

Job Titles Held:

  • Senior Manager, Clinical Quality Assurance
  • Lead Clinical Research Coordinator
  • Program Coordinator I (Clinical Research Coordinator)

Degrees

  • Master of Science
  • Masters
  • Bachelor of Science

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