Katherine Jane Barkan
Fuquay-Varina,NC
Summary
A seasoned clinical research professional with 16+ years in clinical and laboratory research with experience in neurology, oncology, biochemistry, microbiology, and molecular biology, including 9+ years CRO monitoring experience. While at Rho served as an Unblinded Clinical Team Lead for 2 years and managed the Unblinded clinical operations. While being a Senior Clinical Research Associate has monitored for over 30+ clinical trials over a wide variety of disorders. Accomplished presenter, speaker, and instructor known for being a self-starter who is dedicated to advancing scientific discovery while ensuring the rights, safety, and well-being of human subjects.
Overview
21
21
years of professional experience
Work History
Senior Clinical Research Associate
Syneos Health
06.2024 - 08.2024
- Performed monitoring and site management work to ensure that sites were conducting the study and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Senior Clinical Research Associate
Parexel International
07.2023 - 06.2024
- Clinical sites' main point of contact, accountable for quality and delivery of sites from Initiation to Close out of the trial
- Oversaw the conduct of the trial at designated sites ensuring the rights and well-being of human subjects were protected, quality and integrity of the reported data and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP and with the applicable regulatory requirement(s)
- Buillt relationships with investigators and site staff
- Facilitated and supported site with access to relevant study systems and ensured sites were compliant with project specific training requirements
- Addressed and resolved issues at sites, including, questions, potential deficiencies in documentation, communication, and the need for additional training
- Applied working knowledge and judgment to identify and evaluate potential data quality issues
- Determined and implemented appropriate follow-up action with the input of other / relevant parties and / or guidance provided, if applicable
- Actively participated in Investigator and other external or internal meetings and audits & regulatory inspections as required
- Collected, reviewed, and approved (if applicable) updated/amended site documentation, including regulatory documents as applicable
- Reviewed site recruitment plan in collaboration with the site staff on an ongoing basis
- Performed and reported on-site visits and remote contacts in accordance with the monitoring plan; this includes Qualification and Initiation visits; applied judgment and knowledge to independently resolve site issues, questions and concerns
- Assessed and managed test article/study supply including supply, accountability and destruction/return status
- Reviewed site payment status
- Follow-up on CRF data entry, query status, and SAEs
- Conducted on-site study-specific training (if applicable)
- Performed site facilities assessments
- Maintained sound working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL / Sponsor training requirements and study specific procedures, plans and training
- Actively participated in Investigator and other external or internal meetings, audits and regulatory inspections as required.
Unblinded Clinical Team Lead
Rho, Inc.
09.2021 - 07.2023
- Developed project plans and study documents (i.e., clinical monitoring plans, contingency plans, project management plan, study start-up plans, recruitment and retention materials, investigator site file, etc.)
- Ensured high performance and efficiency of the clinical team through trip report review, co-monitoring, and ongoing mentoring of the CRA team
- Provided input to senior management and the leadership team regarding the performance of the CRA team
- Developed and maintained progress reports
- Reviewed and provided input on project plans, tools, and forms (e.g., protocol, project plan, CSR, DMP, CRFs, SAP, SMP, MMP, validation plan, vendor documents, etc.)
- Responsible for management of clinical operational activities from start-up to close-out for assigned projects in compliance with applicable regulations, ICH-GCP Guidelines, and applicable SOPs
- Provided direction and training to CRAs assigned to projects and ensures all project training is completed and documented
- Trained new staff members on departmental processes, regulations, safety practices, documentation requirements and quality assurance standards
- Fostered and supported the management and development of the CRA team
- Provided direction and training to CRAs assigned to projects and ensures all project training is completed and documented
- Ensured sites and CRAs operate in compliance with FDA regulations, protocol, GCP/ICH guidelines and sponsor requirements
- Provided leadership, mentorship and guidance to team members regarding clinical practice policies and procedures
- Supervised the daily operations of the clinical team ensuring timely completion of tasks in accordance with established policies and procedures
- Assessed staffing needs based on fluctuating caseloads and adjusted schedules accordingly
- Created detailed reports summarizing project timelines, budgets and other important metrics
- Led training sessions for new clinical research associates on Good Clinical Practice guidelines
- Collaborated with external vendors to ensure timely completion of all deliverables within quality standards
- Responded to internal and external data queries and audit findings
- Monitored expenditures and adherence to study budgets
- Monitored study activities to verify compliance with protocols and with relevant local, federal, and state regulatory and institutional policies
- Maintained required records of study activity including case report forms, drug dispensation records, and regulatory forms
- Maintained contact with sponsors to schedule and coordinate site visits and to answer questions about issues such as incomplete data
- Prepared study-related protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
Senior Clinical Research Associate
Rho, Inc.
04.2019 - 07.2023
- Managed and conducted site selection process by conducting telephone interviews, administering questionnaires, reviewing Curriculum Vitae, and assessing a potential investigator's ability to conduct a clinical trial
- Conducted pre-study site (selection) visits and/or study initiation visits for the purpose of reviewing the adequacy of the study site to conduct a clinical trial
- At the initiation visit, the CRA will train study site personnel on the protocol, CRF, safety reporting, documentation procedures, regulatory requirements, and study management
- Ensured sites and CRAs operate in compliance with FDA regulations, protocol, GCP/ICH guidelines and sponsor requirements
- Identified and resolved problems at assigned investigative sites to ensure subject safety and the highest possible data quality
- Monitored drug accountability
- Tracked site action items to resolution
- Conducted business in accordance with Rho SOPs, FDA regulations, and ICH/GCP guidelines
- Conducted interim-monitoring visits, to ensure the integrity and quality of clinical data with respect to accuracy, documentation, and methods through the review of CRFs, source documents, medical records, drug accountability logs and regulatory documents
- Conducted site close-out visits for the purpose of inventory and return of clinical supplies, monitors remaining CRFs, resolves outstanding issues, and details document retention policy with the investigator
- Provided verbal and written feedback to study sites regarding overall performance and deficiencies
- Prepared monitoring visit reports and communicated findings to the Sponsor, site personnel, the Rho Clinical Operations management, and the Rho Project Manager
- Prepared for and participated in internal and external audits
- Conducted site regulatory document collection, review, approval and tracking
- Assisted with the management of the electronic Trial Master File (eTMF)
- Fosters and supports the management and development of the CRA team
- Ensured sites and CRAs operate in compliance with the study protocol, applicable SOPs, ICH-GCP guidelines, and applicable regulations
- Conducted feasibility/site identification activities and facilitates site start-up activities.
Senior Clinical Research Associate
Barrow Neurological Institute Clinical Research Organization
11.2016 - 04.2019
- Manage and monitor 18 to 30+ clinical trial sites for multiple trials, including 3 international sites, from site selection and pre-investigation through trial closeout
- Perform on-site and remote site monitoring visits with source data review and verification in accordance with Case of Federal Regulations (CFR), FDA, ICH-GCP guidelines, protocol, and other applicable regulatory requirements
- Serve as subject matter expert for monitoring services for clinical research trials specializing in neurological disorders
- Perform feasibility, pre-study, site initiation, interim, and closeout monitoring visits with appropriate documentation (confirmation letters, follow-up letters, trip reports, and communication logs)
- Ensure Randomization Process completed correctly and that Investigational Product (IP) is received, stored, dispensed, administered, and returned, per protocol
- Ensure trials are conducted, recorded, and reported per protocol, SOPs, ICH-GCP guidelines, and applicable regulatory requirements
- Utilize expertise and judgment to identify and resolve complex site issues and deficiencies
- Utilize experience to critically evaluate performance of site, identify the need for additional training, and provide recommendations regarding site-specific actions
- Understand project scope, budgets, and timelines and be able to provide input and manage objectives to meet timelines
- Quality Control activities include tracking reconciliation/resolution of protocol deviations, site action items, electronic queries, and IP compliance and accountability
- Revise clinical monitoring plans and develop internal monitoring SOPs
- Serve as site liaison to Project Management
- Provide guidance to sites to support enrollment and ensure any issues regarding subject recruitment and retention are quickly identified and addressed
- Create trial case report forms to ensure quality data collection
- Oversee Data Management to ensure relevant, high-integrity data is captured
- Develop monitoring tools and create training materials
- Conduct training of Site Investigators and other site/study personnel on protocol and GCP
- Train, mentor, and supervise new monitoring staff including review and approval of monitoring visit documentation as well as management of activities and monitor visit scheduling
- Ensure appropriate disclosure of adverse and serious adverse events to sponsor and regulatory bodies
- Proactively manage site visit budgets and spending to ensure CRO profitability
- Able to travel as necessary may be up to 75% depending on assignments.
Clinical Research Associate I
SUNY Upstate Medical University
06.2014 - 11.2016
- Responsible for site management as prescribed in the monitoring plan and by group leadership
- Evaluate clinical data documentation, regulatory document review, monitor safety and conduct of study to ensure investigator and site compliance with study protocol, FDA regulations, ICH-GCP guidelines, institutional/CRO SOPs, and HIPAA guidelines
- Provide project updates to principal investigators, project management, and data management
- Conduct on-site and remote monitoring for source document review and verification then complete the appropriate monitor visit documentation including reports, action items logs, and letters
- Act as liaison between sponsor, CRO, and study site
- Provide appropriate internal and external customer service with study sponsors, site personnel, and other departments/organizations.
Emergency Department Technician
St. Joseph's Hospital Health Center
02.2012 - 05.2014
- Obtain biologic samples from and perform ECGs on critically ill infant, child, and adult patients
- Perform point-of-care testing and alert physicians of critical findings necessitating immediate intervention to avoid loss of life and/or limb
- Perform quality control testing of point-of-care equipment and kits
- Assist with placement and patient education of knee, wrist, and shoulder immobilizers
- Participate in the timely admission, transfer, and discharge of patients.
Public Health Technician
Florida Department of Health- Bureau of Laboratories
09.2009 - 04.2011
- Responsible for ensuring Safety Data Sheet binders for all department sections were complete, accurate, current, and accessible per applicable OSHA regulations
- Manage environmental testing clients and served as client advocate for the state of Florida
- Responsible for employee training of safety devices and safety policies for the Virology Department
- Developed Virology Department protocols involving DEP, EPA, and CDC
- Conduct complex assays for the detection of parasites, viruses, and indicators of contamination of environmental waters (protozoa, helminths, and arthropods)
- Participate in tracking, detecting, and research with/involving West Nile Virus, Eastern Equine Encephalitis virus, St
- Louis encephalitis virus, dengue virus, chikungunya virus, California encephalitis group viruses, and malaria
- Train new employees in clinical molecular techniques and methods
- Establish and maintain workplace areas necessary for aseptic procedures as well as clean areas that are RNA and DNA free.
Clinical Laboratory Assistant
Tampa General Hospital
09.2005 - 09.2009
- Responsible for processing and creating appropriate test orders for patient specimens in conjunction with physician and nurse orders
- Organized and assembled proprietary hospital antibiogram for use by physicians in determining appropriate chemical prophylaxis for patients with nosocomial and community acquired infections
- Assisted in hospital research for the Clinical Laboratory Esoteric Department
- Performed assay testing validation of new equipment and testing kits
- Executed assays and tasks in Level One and Level Two BSL Clinical Labs involving contagious and pathogenic microorganisms
- Performed phlebotomy collections for clinical laboratory testing
- Demonstrated knowledge of current HIPPA, CAP, and JCAHO regulations.
Laboratory Assistant and Teacher's Aide
University of Tampa
08.2003 - 06.2006
- Assisted Professors and provided guidance to students during Chemistry course labs
- Synthesized chemicals and prepared equipment for professor demonstration and student use
- Implemented online chemical inventory and ordering system for chemistry department
- Executed laboratory research and projects involving HPLC, NMR, FTIR, MS-GC, and AA Spectrometer
- Prepared, stored, and transferred samples for testing
- Conducted maintenance on laboratory equipment to ensure proper functioning.
Education
Master of Science in Public Health in Specialized in global health and communicable diseases -
University of South Florida
Tampa, FL06.2012
Bachelor of Science in Biochemistry - undefined
University of Tampa
Tampa, FL06.2006
Skills
- Therapeutic area expertise
- Report Writing
- Good Clinical Practices
- Team leadership qualities
- Vendor management experience
- Electronic data capture systems
- Adverse event reporting
- Multitasking abilities
- Clinical trial management
- Coordinating site operations
- Completing regulatory documents
- Site Management
References
References available upon request
Timeline
Senior Clinical Research Associate
Syneos Health
06.2024 - 08.2024
Senior Clinical Research Associate
Parexel International
07.2023 - 06.2024
Unblinded Clinical Team Lead
Rho, Inc.
09.2021 - 07.2023
Senior Clinical Research Associate
Rho, Inc.
04.2019 - 07.2023
Senior Clinical Research Associate
Barrow Neurological Institute Clinical Research Organization
11.2016 - 04.2019
Clinical Research Associate I
SUNY Upstate Medical University
06.2014 - 11.2016
Emergency Department Technician
St. Joseph's Hospital Health Center
02.2012 - 05.2014
Public Health Technician
Florida Department of Health- Bureau of Laboratories
09.2009 - 04.2011
Clinical Laboratory Assistant
Tampa General Hospital
09.2005 - 09.2009
Laboratory Assistant and Teacher's Aide
University of Tampa
08.2003 - 06.2006
Master of Science in Public Health in Specialized in global health and communicable diseases -
University of South Florida
Bachelor of Science in Biochemistry - undefined
University of Tampa
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