Brittney Pfeiffer
Houston,TX
Summary
Experienced Senior Clinical Research Associate II with a demonstrated history of working in the pharmaceutical industry. With Global Lead CRA experience, a member of the CRA advisory board, the lead of unblinded monitoring and mentoring other CRAs. Great collaboration skills with the clinical team and at the site level. Strong research professional skilled in developing study tools, the use of EDC, event management, GCP, Marketing and Clinical Operations.
Overview
15
15
years of professional experience
Work History
Senior CRA II
Syneos Health
Morrisville, North Carolina, USA
02.2022 - Current
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacovigilance Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
- Assesses site processes
- Conducts Source Document Review of appropriate site source documents and medical records
- Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
- Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
- Verifies site compliance with electronic data capture requirements.
- May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving trial documents in accordance with local guidelines and regulations.
- Documents site visit confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, enrollment, and retention activities. Enters data into tracking systems as required to track patient recruitment status and action items to resolution.
- Tracks subject/patient recruitment, budgets, and timelines for own and others activities; proactively communicates site-level activities / communication to ensure project objectives and timelines are met. Must be able to quickly adapt to changing priorities and goals / targets.
- May collaborate with other clinical study site personnel, or in collaboration with the project team, to support all assigned sites and project-specific site management activities compliant with applicable requirements.
Clinical Trial Manager II
Syneos Health
Houston, TX
07.2021 - 02.2022
- Supports primary study Clinical Lead in routine reviews of Clinical Trial Management System (CTMS), Case Report Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrollment, Data Visualization dashboards (where available) to oversee site and study team conduct, to ensure timely entry of all operational aspects (required visits/calls, duration, and frequency) according to plan. Oversees assigned site and study team members’ conduct, and identifies risks to delivery or quality.
- Ensures quality of the clinical monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools.
- Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. Is accountable for their assigned clinical team members’ understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.
- Reviews the completeness of site monitoring documentation (site monitoring visit reports, site visit reports, site letters, and pertinent correspondence), to ensure the proper documentation of site management activities and conduct. Ensures these documents are provided, according to company and/or sponsor specifications, including delivery deadlines.
- Collaborates with other functional departments related to clinical monitoring activities and deliverables.
- Understands the role of other functions’ roles in achieving site delivery according to protocol, ICH/GCP and or Good Pharmacovigilance Practices (GPP) and country regulations. This may include providing input to Quality Assurance (QA). Supports Inspection Readiness activities.
- Provided oversight of CRAs and sites as the Site Relationship and Excellence Partner. Performing routine site visits/quality checks to look for issues/trends across the sites and to ensure the assigned CRAs were taking appropriate action.
Senior Clinical Research Associate II
Lab Corp Covance
Durham, NC, USA
12.2019 - 07.2021
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
- Responsible for all aspects of site management as prescribed in the project plans
- General On-Site Monitoring Responsibilities:
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
- Monitor data for missing or implausible data
- Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy
- Ensure audit readiness at the site level
- Travel, including air travel, may be required and is an essential function of the job
- Prepare accurate and timely trip reports
- Manage small projects under 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 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
- Participate in writing clinical trial reports as assigned
- Interact with internal work groups to evaluate needs, resources and timelines
- Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
- Responsible for all aspects of registry management as prescribed in the project plans
- Discuss feasibility with potential investigators
- Assist in preparation and follow-up on Quality Control (QC) visits when requested
Senior Clinical Research Associate
Novartis
East Hanover, NJ, USA
05.2016 - 08.2019
- Completed regional monitoring of Phase III and IV studies to include evaluation, initiation, monitoring and close out visits; co-monitored Phase III studies to include initiation, monitoring and close out visits; conducted study feasibility and site selection activities; performed telephone monitoring activities in order to obtain study status information; participated in routine study progress meetings, face to face or via teleconference
- Adhered with corporate internal policies and requirements, including submission of timesheets and expense reports in a timely manner; knowledgeable of applicable SOPs, guidelines and study procedures
- Assisted with protocol and CRF review; assisted with the development of study manuals, annotated CRFs, monitoring conventions, tracking forms, site study tools and other study materials
- Mentored for Site Manager, when assigned; conducted on the job training and formal training to other CRAs and Clinical Trial Assistants; conducted and assisted with administrative activities as a member of the project team
- Reviewed study visit reports, follow up letters and site communication generated by other CRAs for timeliness, quality, consistency and appropriate documentation and resolution of issues, with support from the Clinical Team Lead, Regional Monitoring Manager or Clinical Operations Manager as needed
- Trained study coordinators/investigators as necessary to assure accurate and complete data collection; developed and implemented innovative approaches for and participated in site recruitment, selection and initiation activities
- Coordinated timely shipment of clinical supplies and study drug to sites; ensured proper storage, dispensation and accountability of clinical supplies and study drug; followed up of drug safety issues and safety reports in timely manner, if applicable
- Maintained adequate site tracking records; prepared/reviewed all patients tracking records; established and maintained good rapport with study sites; assisted with data query form (including query process)
- Ensured the integrity of clinical data and adherence to applicable regulatory, protocol and SOP requirements; communicated site study issues, concerns and progress to Clinical Research Manager, Project Manager, Clinical Team Lead, Regional Monitoring Manager and Clinical Operations Manager accordingly; developed and implemented corrective actions when appropriate
Senior Clinical Research Associate
PRA (Dedicated to Novartis)
East Hanover, NJ, USA
03.2012 - 05.2016
- Completed regional monitoring of Phase III and IV studies to include evaluation, initiation, monitoring and close out visits; co-monitored Phase III studies to include initiation, monitoring and close out visits; conducted study feasibility and site selection activities; performed telephone monitoring activities in order to obtain study status information; participated in routine study progress meetings, face to face or via teleconference; adhered with corporate internal policies and requirements, including submission of timesheets and expense reports in a timely manner; knowledgeable of applicable SOPs, guidelines and study procedures
- Prepared timely visit reports for site visits and interacted with investigators and coordinators at sites; wrote study visit reports and follow up letters within the timeline established by applicable SOPs and guidelines
- Assisted with protocol and CRF review; assisted with the development of study manuals, annotated CRFs, monitoring conventions, tracking forms, site study tools and other study materials
- Mentored for Site Manager, when assigned; conducted on the job training and formal training to other CRAs and Clinical Trial Assistants; conducted and assisted with administrative activities as a member of the project team
- Reviewed study visit reports, follow up letters and site communication generated by other CRAs for timeliness, quality, consistency and appropriate documentation and resolution of issues, with support from the Clinical Team Lead, Regional Monitoring Manager or Clinical Operations Manager as needed
- Trained study coordinators/investigators as necessary to assure accurate and complete data collection; developed and implemented innovative approaches for and participated in site recruitment, selection and initiation activities
- Coordinated timely shipment of clinical supplies and study drug to sites; ensured proper storage, dispensation and accountability of clinical supplies and study drug; followed up of drug safety issues and safety reports in timely manner, if applicable
- Maintained adequate site tracking records; prepared/reviewed all patients tracking records; established and maintained good rapport with study sites; assisted with data query form (including query process)
- Ensured the integrity of clinical data and adherence to applicable regulatory, protocol and SOP requirements; communicated site study issues, concerns and progress to Clinical Research Manager, Project Manager, Clinical Team Lead, Regional Monitoring Manager and Clinical Operations Manager accordingly; developed and implemented corrective actions when appropriate
- As Global Lead Unblinded Clinical Research Associate, performed all below duties of Senior CRA in addition to assisting Global Clinical Trial Leader with Management of clinical research sites and CRAs globally on 4 clinical studies;
- As Global Lead CRA for pediatric Heart Failure, developed the study monitoring plan and study tools for the CRAs in addition to assisting the Global Clinical Trial Leader with management of clinical trial sites and CRAs globally. As the Global Lead, 1 site was assigned to me to be in the field to be able to relate and assist other CRAs.
Clinical Research Associate
Novartis
East Hanover, NJ, USA
12.2010 - 03.2012
- Previously responsible for regional monitoring of Phase III and IV studies to include evaluation, initiation, monitoring and close out visits
- Prepared timely visit reports for site visits and interact with investigators and coordinators at sites
- Ensured clinical study activities were conducted to comply with Good Clinical Practice (GCP) and applicable regulatory requirements set forth by the FDA and ICH
- Co-monitored Phase III studies to include initiation, monitoring and close out visits
- Researched, recorded and resolved queries arising from data review
- Prepared monthly reports on all activities for Regional Manager
Education
Bachelor - Consumer Science
University Of Houston
Houston, TX 12-2009
Skills
- IMPACT Experience
- EConsent
- Veeva CPSS activity
- CTMS
- Veeva Vault
- Veeva EDC
- Suvoda
- Oracle EDC
- Greenphire vendor
- Study tool creation
- Teamwork and collaboration
- Problem-solving
- Flexible and adaptable
- Excellent communication
- Critical thinking
- Organization and time management
THERAPEUTIC EXPERIENCE
- THERAPEUTIC AREA
- INDICATION
- SUB-INDICATION
- Cardiovascular
- Cardiac arrhythmias
- Atrial fibrillation (AF)
- Generalized CVD
- Hypertension (HTN)
- Ischemic heart disease
- Acute decompensated heart failure (ADHF)
- Angina pectoris
- Angina, unstable
- Chronic heart failure (CHF)
- Coronary artery disease (CAD)
- Myocardial infarction, acute (AMI)
- Stroke
- Stroke, acute
- Dermatology
- Dermatoses
- Psoriasis
- Endocrinology/Metabolism
- Hormone disorders
- Hyperparathyroidism
- Hematology
- Thrombo-embolic disorders
- Thrombosis
- Hepatology
- Hepatic disorders
- Nonalcoholic steatohepatitis (NASH)
- Immunology
- Rheumatology
- Arthritis, rheumatoid
- Infectious Disease
- Respiratory infections
- COVID-19 treatment
- Nephrology
- Kidney diseases
- Chronic kidney disease (CKD)
- Neurology
- Autoimmune disorders
- Multiple sclerosis (MS) unspecified
- Obstetrics/Gynecology
- Not Available
- Psychiatry
- Behavioral and emotional disorders
- Attention deficit disorder/hyperactivity (ADD/ADHD)
- Respiratory
- Chronic obstructive airways disease
- Asthma
- COAD/COPD
Languages
English
Native or Bilingual
Spanish
Elementary
Timeline
Senior CRA II
Syneos Health
02.2022 - Current
Clinical Trial Manager II
Syneos Health
07.2021 - 02.2022
Senior Clinical Research Associate II
Lab Corp Covance
12.2019 - 07.2021
Senior Clinical Research Associate
Novartis
05.2016 - 08.2019
Senior Clinical Research Associate
PRA (Dedicated to Novartis)
03.2012 - 05.2016
Clinical Research Associate
Novartis
12.2010 - 03.2012
Bachelor - Consumer Science
University Of Houston