APRIL D. BLAIR
Dallas,TX
Summary
Motivated professional offering Master of Science and post graduate experience in clinical research and healthcare management. Adds value to any organization in need of great collaboration, interpersonal and multitasking abilities with excellent research, technical, and problem-solving skills. Skilled in working under pressure to meet tight deadlines and adapting to new situations and challenges to best enhance the organizational brand.
Overview
15
15
years of professional experience
Work History
Consultant/ Contract
IQVIA Oncology
06.2021 - 04.2023
- Monitored investigator sites for good clinical practice (GCP) compliance according to Pharma Net standard operating procedures (SOPs) and client guidelines for a company that facilitates drug development via comprehensive clinical development services
- IND services in oncology-endometrial cancer and solid tumors
- Served as the subject matter expert (SME) for the clinical trial manager (CTM) on monitoring related activities
- Ensured adherence to the initial scope of work, budget, and study deliverables through proposal meeting participation with potential clients and clinical vendor management and payments
- Resolved issues, questions, and requests for additional study supplies and study payments
- Train and mentor clinical research associates (CRAs) on monitoring, internal procedures, query resolutions, and preparation for Sponsor audits for clinical studies
- Work closely with the Program Management to develop, implement, and manage the Quality Program for the Client, including the design and construction phases of each element and program-wide activities
- Work on multiple projects and adhere to sponsor guidelines in communication with site staff to meet deliverables and study metrics.
Consultant/ Contract
Pfizer COVID Vaccines
06.2021 - 08.2022
- Monitored investigator sites for good clinical practice (GCP) compliance according to Pharma Net standard operating procedures (SOPs) and client guidelines for a company that facilitates drug development via comprehensive clinical development services
- IND services in oncology-endometrial cancer and solid tumors
- Served as the subject matter expert (SME) for the clinical trial manager (CTM) on monitoring related activities
- Ensured adherence to the initial scope of work, budget, and study deliverables through proposal meeting participation with potential clients and clinical vendor management and payments
- Resolved issues, questions, and requests for additional study supplies and study payments
- Train and mentor clinical research associates (CRAs) on monitoring, internal procedures, query resolutions, and preparation for Sponsor audits for clinical studies
- Work closely with the Program Management to develop, implement, and manage the Quality Program for the Client, including the design and construction phases of each element and program-wide activities.
Covance by LabCorp
Dallas, TX
11.2019 - 05.2021
- Monitored investigator sites for good clinical practice (GCP) compliance according to Pharma Net standard operating procedures (SOPs) and client guidelines for a company that facilitates drug development via comprehensive clinical development services
- IND services in oncology-endometrial cancer and solid tumors
- Served as the subject matter expert (SME) for the clinical trial manager (CTM) on monitoring related activities
- Ensured adherence to the initial scope of work, budget, and study deliverables through proposal meeting participation with potential clients, and clinical vendor management
- Resolved issues, questions, and requests for additional study supplies and study payments
- Train and mentor clinical research associates (CRAs) on monitoring, internal procedures, query resolutions, and preparation for Sponsor audits for clinical studies
- Prepare accurate and timely trip reports
- Clinical Study Lead to manage small projects under the direction of a Project Manager/Director as assigned
- Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned
- Review the progress of projects and initiate appropriate actions to achieve target objectives
- Organize and make presentations at Investigator Meetings
- Participate in the development of protocols and Case Report Forms as assigned
- Work closely with the Program Management to develop, implement, and manage the Quality Program for the Client, including the design and construction phases of each element, as well as program-wide activities
- Reviews Quality Manuals, documents, and implementation procedures to verify compliance with industry codes and standards, and regulations
- Undertake feasibility work when requested
- Conduct, report, and follow up on Quality Control (QC) visits when requested
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings, and other tasks as instructed by supervisor as assigned
- Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned.
PRA Health Sciences, Inc. / Vertex (Sponsor)
Dallas, TX
04.2018 - 09.2019
- Monitored investigator sites for good clinical practice (GCP) compliance according to Pharma Net standard operating procedures (SOPs) and client guidelines for a company that facilitates drug development via comprehensive clinical development services
- IND services in immunology- cystic fibrosis and other autoimmune diseases
- Ensured adherence to the initial scope of work, budget, and study deliverables through proposal meeting participation with potential clients, and clinical vendor management
- Resolved issues, questions, and requests for additional study supplies and study payments
- Train and mentor clinical research associates (CRAs) on monitoring, internal procedures, query resolutions, and preparation for Sponsor audits for clinical studies
- Work closely with the Program Management to develop, implement, and manage the Quality Program for the Client, including the design and construction phases of each element, as well as program-wide activities
- Reviews Quality Manuals, documents, and implementation procedures to verify compliance with industry codes and standards, and regulations.
Provident Research, Inc. / Johnson & Johnson (Sponsor)
Dallas, TX
04.2017 - 03.2018
- Assisted the management of large and small-scale orthopedic and arthroplasty clinical trials and medical device projects, ensuring on-time, on-budget performance for a clinical research organization
- Negotiated study budgets with investigators and ensured all device supplies and equipment were available and within expiry date before surgery
- Review and approve trip reports within the Sponsor timeline
- Review and re-write SOPs for quality adherence and assist with developing and implementing clinical Standard Operating Procedures (SOPs) for clinical site best practices.
Syneos (formerly InVentiv Health / Amgen (Sponsor))
Dallas, TX
03.2016 - 04.2017
- Provided clinical/scientific input during the development and execution of oncology, lymphoma, hematology, cardiovascular, and cardiac arrhythmia device trials
- Develop and improve relationships with critical Suppliers through projects and improvement quality strategies
- Conducted oncology registry management as prescribed in the project plans and reviewed Sponsor SOPs to ensure site adherence to study timelines and Sponsor guidance
- Maintained the Trial Master File (TMF) and Investigator Site Files (ISFs) for the duration of the study, ensuring essential documents were filed appropriately and assisting the file review and reconciliation process in preparation for FDA and Sponsor audits
- Managed the progress of assigned studies ICH/GCP knowledge by tracking regulatory submission dates and approvals, recruitment and enrollment timelines and case report form (CRF) completion, DET submission, and data query generation/resolution timelines
- Develop Corrective and Preventative Action (CAPA) plans for issues of non-compliance for quality and QA related to clinical development (ICF consenting process, ICG/ GCP documentation, and safety assessments within a timely manner).
IQVIA (formerly Quintiles/ Pfizer)
Dallas, TX
10.2012 - 03.2016
- Provided monitoring visits and site management for a variety of oncology – solid and gastric tumor protocols that were complex and required knowledge in advanced therapeutic areas of pain management, cardiovascular, and Alzheimer’s disease
- Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations and escalated site quality issues to the Clinical Project Manager (CPM) and Line Manager per observation visit and monitoring plan
- Facilitated sponsored audits related to quality issues and GCP/ICH guidelines for CAPA resolutions-(safety review timelines, ICF consenting, and GCP documentation processes)
- Assist in establishing robust and consistent evaluation methodology, ensuring reporting of adverse events is consistently applied across all clinical sites.
Baylor Scott & White Research Institute
Dallas, TX
11.2010 - 10.2012
- Assured continual GCP, International Conference on Harmonization (ICH,) and SOP compliance with the National Institute of Health (NIH) and physician-initiated (PI) studies and sponsored clinical trials from the bench to the medical facility or clinic
- Writing and revising SOP for clinical site process and study timeline guidance
- Provide Quality Systems leadership using recognized standards as the basis for process development and optimization, procedure development, data collection, and Quality Systems training
- Work closely with the Program Management to develop, implement, and manage the Quality Program for the Client, including the design and construction phases of each element, as well as program-wide activities
- Develop and improve relationships with critical Suppliers through projects and improvement strategies
- Manage a team of quality program managers building and improving the data transformation quality processes.
UT Southwestern Medical Center
Dallas, TX
10.2008 - 11.2010
- Supervised and managed study budget; reviewed potential studies for participation and collaboration for Sponsor ischemic and hemorrhagic stroke trials for medical device and IP
- Performed telephone and face-to-face screening for potential study subjects
- Conducted study activities related to the timeline schedule and performed essential duties assigned to a lead study coordinator
- Entered data into the EDC system per Sponsor data entry timeline and performed query resolution in preparation for database lock.
Education
Ph.D. - Health Administration
Franklin University – School of Nursing Health Sciences
true03-2024
MBA -
LSUS-Shreveport School of Business Management
09.2023
Master of Science, Social work Administration and Research -
The University of Texas at Arlington
01.2003
Bachelor of Science, Social Work Administration -
University of North Texas
01.1999
Skills
- Lead Clinical Research Associate
- CRA monitoring experience (SEVs, Initiation – Closeout), site and CRA management, schedule and coordinate team and study meetings
- Assist with the preparation of external and internal documents
- Strong leadership solution focus within a stressful working environment, successfully adhering to demands while meeting deliverables and ensuring document compliance
- GCP training for clinical sites and operational partners to follow GCP/ ICH guidelines and training provided in preparation for US FDA inspection readiness
- Strong quality management, with at least twelve years of experience managing teams, ideally hands-on quality improvement and clinical development
- Technical skills in manufacturing solid oral doses, semi-solids, medical devices, biologic's, vaccines-COVID-19, Seasonal Influenza- FLU, Meningococcal disease, and Pneumococcal, Cystic fibrosis disease worked across all Phases (I - IV) of clinical development
- Successful at building strong cross-functional teams to work together and accomplish highly complex projects on time and within project budget and vendor management
- CAPA reconciliation and resolution
- Systems: eTMF, Wingspan, CTMS, Veeva Vault, Medidata RAVE, Oracle Inform
- Project Planning
- Decision-Making
- Problem-Solving
- Written Communication
- Microsoft Office
- Communication
- Multitasking
- Team Building
- Organization and Time Management
- Data Management
- Interpersonal Communication
References
References available upon request.
Timeline
Consultant/ Contract
IQVIA Oncology
06.2021 - 04.2023
Consultant/ Contract
Pfizer COVID Vaccines
06.2021 - 08.2022
Covance by LabCorp
11.2019 - 05.2021
PRA Health Sciences, Inc. / Vertex (Sponsor)
04.2018 - 09.2019
Provident Research, Inc. / Johnson & Johnson (Sponsor)
04.2017 - 03.2018
Syneos (formerly InVentiv Health / Amgen (Sponsor))
03.2016 - 04.2017
IQVIA (formerly Quintiles/ Pfizer)
10.2012 - 03.2016
Baylor Scott & White Research Institute
11.2010 - 10.2012
UT Southwestern Medical Center
10.2008 - 11.2010
Ph.D. - Health Administration
Franklin University – School of Nursing Health Sciences
MBA -
LSUS-Shreveport School of Business Management
Master of Science, Social work Administration and Research -
The University of Texas at Arlington
Bachelor of Science, Social Work Administration -
University of North Texas