Florence Dekontee Toe
Houston
Summary
I am a Senior clinical Research Associate/lead CRA with over a decade of experience in clinical research. Known for my approachable demeanor and adeptness in fostering strong relationships, I excel in clinical research practices, demonstrating analytical, problem-solving, and multitasking abilities.
My strong organizational, administrative, and relationship-building skills have enabled me to develop creative solutions for enhancing relationships with site staff, colleagues, and ensuring patient safety and data integrity. I am seeking to join a team that values communication and teamwork, where I can utilize my skills and knowledge and continue to grow.
Overview
13
13
years of professional experience
Work History
Sr. Clinical Research Associate
KCR CRO
Houston
06.2023 - Current
- Company Overview: FSP at Merck, Houston / TX, US
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents
- Gains an in-depth understanding of the study protocol and related procedures
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready
- Participates & provides input on site selection and validation activities
- Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased; Subjects’ right, safety and well-being are protected
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
- Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
- Identifies, assesses, and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed
- Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines
- Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required
- Supports and/or leads audit/inspection activities as needed
- Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities
- Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate
- FSP at Merck, Houston / TX, US
Sr. Clinical Research Associate
Precision for Medicine
Houston
06.2022 - 06.2023
- Independently oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports
- Manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC, and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager
- Review site regulatory documents and confirmed sites meets the enrollment qualifications
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
- Establishes, updates, tracks, and maintains study specific trial management tools/systems, and status reports
- If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate
- 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
- Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs
- Performs Monitoring Oversight Visits to assess other CRA team members
- Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote)
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements
- Supports subject/patient recruitment, retention and awareness strategies
- Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
- 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 essential documents in accordance with local guidelines and regulations
- Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues
- Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image
- Performs 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
- Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
- Identifies and processes Serious Adverse Events according to the procedures defined by the study team
- Also demonstrates a full understanding of the SAE reporting process
- Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies
- Owns the timely and appropriate resolution of the risk with oversight from project team
- Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings
- Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements
- May prepare or assist in preparation of study-specific presentations/training materials and tools
- Assists the team managers in the preparation and review of protocols and other study documentation
- Supports the design and development of CRFs and clinical trial documents as they pertain to clinical monitoring activities (i.e
- Operating manuals, monitoring guidelines, etc.)
- Assists with review of clinical study reports
- Functions as a mentor, assisting with the training and developing of new employees and junior monitors
- Interacts with client, participates in proposal activities, including development and client presentations
- Initiates payment requests for investigators
- Travels as necessary according to project needs
- Performs other duties as assigned by management
Clinical Research Associate II
KCR CRO
Houston
12.2020 - 06.2022
- Perform feasibility for potential sites as requested
- Responsible for all aspects of study site monitoring including pre-study and initiation visits, routine monitoring, close-out visits and continuous maintenance of Investigator/Site Files
- Ensures that the site staff who will conduct the protocol have received proper materials and instructions to safely enter patients into the study
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
- Ensures the protection of study patients by verifying that informed consent procedures and protocol requirements are performed according to the applicable regulatory requirements
- Ensures 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
- Ensures the resources of the Sponsor and KCR 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 KCR travel policy
- Ensures that all issues, deviations, and violations are reported to Clinical Project Manager/ Clinical Project Leader
- Ensures implementation of all other assigned responsibilities/activities described in Project Monitoring Plans, Project Communication plans and other project-specific documents
- Supervises Serious Adverse Event (SAE) reporting process on all stages, including preparation of the report, narratives and follow up of SAEs in assigned sites
- Performs CRF review; query generation and resolution against established data review guidelines on KCR or client data management systems in assigned studies
- Undertakes feasibility work when assigned by Line Manager
- Maintains quality control of assigned parts of Trial Master File (incl
- Site-related documentation)
- Assists with training and development of new employees, performs co-monitoring visits, provides training sessions, aids in monitoring in other sites including other countries of KCR if assigned by Line Manager
- Performs special tasks assigned by Line Manager
- Liaises with vendors, partners, subcontractors
- Participates in teleconferences and meetings with Sponsor or/and study staff
Clinical Research Associate II
Syneos Health
Houston
08.2018 - 09.2020
- Company Overview: FSP at AbbVie, Houston/TX, US
- Primary Site Monitor for phases I, II, and III Oncology Clinical Trials
- Managed activities of the investigative site to ensure successful execution of the protocol
- Oversaw regulatory submissions of site regulatory documents, including the protocol and the consent
- Preparation and presentation at team and regional meetings
- Performed independent site management responsibilities
- Prepared and submitted written reports of monitoring findings
- Conducted on-site and remote monitoring visits, including site qualification, site training, site initiation, interim monitoring, and closeout visits
- Maintained a strong relationship with the investigator and site staff
- Ensured clinical trials were conducted, recorded, and reported in accordance with the protocol, GCP, SOPs, and applicable global, local and regulatory requirements and company objectives
- Reviewed protocol for operational feasibility and organized assessments ensuring appropriate site selection
- Conducted assigned clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives
- Maintained required documentation in the Investigator File and maintains of the site eTMF
- Ensured safety and protection of study subjects according to the monitoring plan, the company’s SOPs, ICH Guidelines and federal regulations
- Verified site staff qualifications, including proper delegation and training, and ensured training documents remained at an acceptable standard throughout the duration of the clinical trial
- Ensured all regulatory approvals were obtained before initiation visits were conducted and appropriate documentation is available in the house
- Conducted IP accountability and reviewed the storage conditions to ensure compliance
- Reviewed data entry progress and worked with site to ensure compliance with timelines
- Discussed recruitment progress, issues, and plans to mitigate hurdles and drive enrollment to success
- Identified and discussed any study issues and updates to ensure the success of the clinical trial
- Actively followed up with sites about pending action items and queries in a timely manner
- Ensured timely and complete reporting of AEs, SAEs, AESIs, and pregnancies, according to agreed procedures
- FSP at AbbVie, Houston/TX, US
Study Coordinator
MD Anderson Cancer Center
Houston
11.2015 - 08.2018
- Managed day-to-day activities of assigned clinical research protocols
- Interviewed, screened, and recruited patients for study, explained process and procedures to educate patients regarding the research study
- Led patient interviews to evaluate patient eligibility in the study
- Collected research data and maintained records for clinical study and regulatory documents
- Managed research subject appointments for tests and procedures such as laboratory tests and x-rays
- Corresponded with patient, and sponsors throughout the study
Clinical Research Coordinator
Gulf Coast Medical Research
Sugarland
02.2012 - 01.2015
- Worked on Phase II, III, and IV clinical research
- Screened charts to find eligible subjects, subjects’ recruitment, and data entry
- Screened subject according to protocol inclusion/exclusion criteria and explained study process
- Communicated with physicians, pharmaceutical company sponsors and regulatory agencies
- Drew blood, processed, and shipped all specimens according to sponsor requirements
- Created, completed, and maintained source documents and entered them into the EDC
- Monitored site initiation visits, site monitoring visits, closeout visits and answered all queries as needed
- Maintained all trial-related documentation and obtained signatures
- Completed site’s feasibility questionnaire and drug accountability records and dispensed IP per protocol
Education
BSHS - Bachelor of Science in Clinical Research Administration
The George Washington University
01.2018
MSHS - Master of Science in Clinical Research Administration
The George Washington University
01.2019
Skills
- Rise-based clinical monitoring skills
- Unblinded CRA
- Inhouse CRA
- Field CRA
- Medical/therapeutic area knowledge
- Medical terminology
- ICH GCPs knowledge
- Regulatory knowledge
- Procedural document knowledge
- Critical thinking skills
- Root cause analysis
- Problem solving
- Risk Based Monitoring concepts
- Oral communication skills
- Written communication skills
- Customer focus
- Listening skills
- Attention to detail
- Organizational skills
- Time management skills
- Interpersonal skills
- Flexibility
- Adaptability
- Teamwork
- Independence
- Computer skills
- Microsoft Office
- Smartsheet
- Software learning ability
- Presentation skills
- English language skills
- Grammar skills
- Progressive knowledge
- Skills and abilities in CRA level
Therapeutic Areas
- I/II, Oncology, Advanced Solid Tumors (Head and neck cancer, Prostate cancer, Non-Small Cell Lung Cancer, and Triple negative breast cancer, and Metastatic Breast Cancer, CE-10- IVD), US, Three sites, 20 subjects total., Clinical Research Associate
- I, Oncology (Unresectable or Metastatic Neoplasms), US, Four Sites, 58 subjects total., Clinical Research Associate
- II, Oncology - Hematology, US, Two sites, 4 subjects total., Clinical Research Associate
- III, Oncology (Hematology, acute Myeloid Leukemia and Lymphocytic Leukemia), US, Three sites, 4 subjects total., Clinical Research Associate
- I, Brain Neurotherapy (AAV2-GDNF / Parkinson’s disease), US, Two sites, 6 subjects total., Clinical Research Associate
- I/b, Brain Neurotherapy (Multiple System Atrophy, MSA), US, One site 5 subjects total., Clinical Research Associate
- II/IV, Cardiology, Coronary artery disease, heart attack, heart failure, aorta disease, stroke, rheumatic heart disease, US, Three sites, 120 subjects total., Clinical Research Coordinator
- II/IV, Pulmonology, COPD, US, Three sites, 90 subjects total., Clinical Research Coordinator
- III/IV, Rheumatology, Diabetes Types I and II, US, Three Sites, 160 subjects total., Clinical Research Coordinator
- I/II, Rheumatology, Diabetes Type II Device (ITCA 100, 60, 650), US, Two Sites 10 subjects., Clinical Research Coordinator
- I, Acute Contagious Diseases, (COVID-19 Diagnostic PCR kit, Smallpox, and RSV), US, Two Sites, 140 Subjects., Clinical Research Associate
- I, Pain, Acute and Chronic (back, knee, Shoulder), US, Two Sites, 200 Subjects., Clinical Research Associate
Timeline
Sr. Clinical Research Associate
KCR CRO
06.2023 - Current
Sr. Clinical Research Associate
Precision for Medicine
06.2022 - 06.2023
Clinical Research Associate II
KCR CRO
12.2020 - 06.2022
Clinical Research Associate II
Syneos Health
08.2018 - 09.2020
Study Coordinator
MD Anderson Cancer Center
11.2015 - 08.2018
Clinical Research Coordinator
Gulf Coast Medical Research
02.2012 - 01.2015
BSHS - Bachelor of Science in Clinical Research Administration
The George Washington University
MSHS - Master of Science in Clinical Research Administration
The George Washington University
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