Dharti Patel
Seattle,WA
Summary
My fervor resides in advancing medical science through the intricacies of clinical trials, offering a beacon of hope to individuals in search of breakthrough treatments and therapies. I'm an experienced Clinical Trial Management Associate dedicated to thriving in dynamic settings. With a track record of adeptly coordinating and supervising trials, I prioritize regulatory compliance and project timelines. Committed to continuous learning, I aim to enhance quality and productivity across trial management phases.
Overview
9
9
years of professional experience
Work History
Clinical Trial Management (CTM) Associate - Oncology
Gilead Sciences,INC.
11.2021 - Current
- Provided comprehensive study-level oversight and leadership for multiple global trials within cross-functional environment, effectively managing activities from start-up through study closure
- Supported Study Project Manager in strategic leadership of cross-functional teams, facilitating stakeholder engagement and ensuring adherence to deliverables and timelines
- Acted as US Country lead for Phase-3 trial, honing strategic decision-making skills, collaborating with CRO partners to conduct site oversight and management, and successfully resolving critical issues at high-risk sites
- Led study vendors by building strong vendor/client relationships, which included developing and reviewing Scope of Work, overseeing invoices, ensuring deliverable quality, and facilitating vendor close-out
- Directed patient recruitment management efforts by orchestrating global recruitment strategies and mitigation planning, including development of meeting agendas, slides, and leading site/Principal Investigator (PI) meetings
- Conducted leadership of assigned meetings, both cross-functional (internal) and with external vendors and investigators, providing regular updates on study status to key stakeholders
- Ensured inspection readiness and supported regulatory compliance through meticulous Trial Master File (TMF) filing and completeness checks
- Identified, mitigated, and managed risks associated with clinical trials, promptly addressing issues through thorough review and escalation procedures
- Led various study tasks, including Monitoring Visit Report (MVR) report review, Protocol Deviation oversight, country management, Consent review, Urgent Safety Measure (USM) management, Source Data Validation (SDV) oversight, and Data query metrics analysis
- Co-developed and managed essential study materials, such as protocols, Master Informed Consent Forms, study plans, regulatory submissions, patient-reported outcome measures, and Contract Research Organization (CRO) training materials
- Managed Clinical Trial Management Systems (CTMS) and electronic Trial Master File (eTMF) to ensure compliance and support trend analyses
- Oversaw Electronic Data Capture (EDC), Interactive Response Technology (IRT), and electronic Patient Reported Outcomes (ePRO) systems, actively leading in user acceptance testing and system management activities
- Managed investigational product and other associated study supplies, ensuring proper handling and accountability
- Facilitated final study sample and consent reconciliation by collaborating with other Functional Area (FA) leads, supporting Long Term Storage (LTS) of final study samples
- Conducted engaging training sessions to educate fellow teammates, including study team members, CRO partners, and vendors
- Assisted Patient Safety team with Adverse Event/Serious Adverse Event reconciliation and query resolution
- Supported global submission strategies and actively participated in process improvement initiatives to enhance study efficiency
- Supported Clinical Study Report (CSR) development, finalization, and UK Final Report submission
- Assisted with ClinicalTrials.gov study updates by collaborating with Disclosure and Transparency group as part of ClinOps personnel
- Mentored junior team members to foster their professional development and ensure their success within organization.
Clinical Project Associate (Oncology)
Gilead Sciences,INC.
01.2021 - 11.2021
- Spearheaded Global Principal Investigator (PI) change and Investigator Safety Letter (ISL) process improvement initiatives, enhancing efficiency and compliance
- Developed and maintained comprehensive storyboards at both study and program levels, providing clear visual representations of project progress and milestones
- Managed Clinical Trial Management Systems (CTMS) for assigned studies, overseeing site creation, contact updates, site activation dates, and PI change requests to ensure accurate and up-to-date information
- Collaborated closely with Contract Research Organization (CRO) partners to obtain essential site contact information and facilitate effective communication channels
- Orchestrated the creation of GAP packs prior to site activation and facilitated the distribution of Investigational New Drug (IND) Safety letters to CRO partners
- Led the tracking of 1572s, Curriculum Vitae (CVs), and Investigator Manuals (IMs), uploading them to the Regulatory Document Management System (RDMS) to maintain regulatory compliance
- Maintained Study Management Team (SMT) charters, meeting invitations, and distribution lists, and meticulously prepared and disseminated SMT meeting minutes to the study team
- Facilitated Clinical Operations team meetings, fostering collaboration and communication among team members
- Conducted reviews such as Pre-Study Visit (PSV) Reports, Trial Master File (TMF) Functional Quality Control (QC), and Interactive Response Technology (IXRS) test scripts
- Acted as a primary point of contact for Electronic Data Capture (EDC) access for assigned studies, ensuring seamless data management processes
- Filed documents promptly in the electronic Trial Master File (eTMF) and Study SharePoint to maintain document traceability and accessibility
- Assisted in Confidential Disclosure Agreement (CDA) checks, proactively requesting new CDAs from sites, and monitored site contract status on a weekly basis by collaborating closely with the Development Business Operations (DBO) team.
Clinical Lab Associate (Molecular Biology Lab)/ Lab Processor (Covid Samples)
Lifescan laboratories INC.
05.2020 - 09.2020
- Collected samples from accessioning and meticulously sorted them into appropriate racks, ensuring accuracy and efficiency in sample handling
- Entered and accessioned Covid samples into SLAB software, employing double-checking process to verify names and dates of birth on tubes and requisitions
- Managed specimens' library within established time frames, adhering to all Personal Protective Equipment (PPE) requirements to maintain safety standards
- Performed Quality Assurance/Quality Control (QA/QC) duties as assigned, maintaining the integrity and reliability of laboratory processes
- Prepared samples for RNA extraction and conducted daily maintenance of the TECAN system used for RNA extraction via magnetic beads
- Loaded and unloaded samples for DNA/RNA extraction, following standard operating procedures to ensure accuracy and precision
- Conducted aliquots for tests using precise pipetting techniques, employing alcohol and flame sterilization methods to prevent cross-contamination between samples
- Prepared reagents and viral buffers required for extraction processes, maintaining inventory and ensuring availability for ongoing operations
- Assisted with departmental quality and process improvement projects, contributing to the enhancement of laboratory efficiency and effectiveness
- Utilized various laboratory computer systems for labeling, inquiry, crediting, and resulting as needed, ensuring accurate documentation and reporting
- Followed proper protocols for the disposal of biohazardous and chemical waste, maintaining a safe and clean laboratory environment in compliance with regulations.
Clinical Lab Associate/ Lab Accessioner (Patient Sample Management - Cytology)
IDEXX laboratories (Illinois Veterinary lab)
10.2019 - 04.2020
- Proactively organized and filed requisition forms in chronological order upon receiving patient samples, ensuring efficient sample management and retrieval
- Maintained high level of accuracy in all assigned tasks and training objectives, demonstrating attention to detail and adherence to standard operating procedures
- Stored and disposed of samples in accordance with established Standard Operating Procedure (SOP) guidelines, maintaining compliance with regulatory requirements and laboratory safety standards
- Reviewed, transcribed, and accurately entered specimen data into LYNXX system, facilitating proper tracking and documentation of sample information
- Collaborated effectively with team members to ensure compliance with applicable regulations and standards, contributing to a culture of quality and safety in the laboratory environment
- Received training in handling various sample types, including micros, Exotics, histos, cytos, and Enzyme-Linked Immunosorbent Assay (EIA) samples, expanding knowledge and proficiency in sample management procedures
- Prepared CBC slides and performed centrifugation of whole blood specimens to separate serum for Serology/Immunology testing, following established protocols to maintain sample integrity
- Prepped samples for EIA/ELISA testing, processing Immunoassays for total estrogens in plasma, and ensuring accurate and reliable test results.
Clinical Research Assistant Intern - Dermatology
Weisman Institute of Cosmetic Surgery
01.2019 - 10.2019
- Shadowed plastic surgeons during surgeries, meticulously recording information pertaining to Rhinoplasty and Eyelid procedures, demonstrating keen observation skills and attention to detail
- Acquired additional knowledge in emerging innovations and techniques such as BOTOX, Fibroblast, Facial implants, and Laser Resurfacing in skincare, with a focus on addressing diverse skin tones
- Demonstrated proficiency in sterilizing surgical instruments, ensuring adherence to strict hygiene and safety protocols in the operating room
- Transferred paper-based data to computer databases, maintaining accurate and organized records for easy retrieval and analysis
- Assisted in the scheduling and monitoring of clinical trial participants, ensuring compliance with study protocols and timelines
- Compiled and organized research data to generate comprehensive reports and graphs, following specific protocols required for Institutional Review Board (IRB) approval
- Designed survey instruments and questionnaires to gather targeted research data, actively participating in the monitoring of clinical trials to ensure data accuracy and integrity
- Collected Bio-Statistical data for subsequent analysis related to clinical trials, contributing to the generation of meaningful insights and conclusions.
Research Assistant (Microbiology Department)
East West University
01.2018 - 11.2018
- Conducted Gram staining of specimen slides, ensuring proper preparation for microscopic analysis and observation
- Executed DNA/RNA extraction and protein extraction procedures from biological samples, following established protocols to maintain sample integrity and quality
- Conducted and interpreted multiple Polymerase Chain Reaction (PCR) assays to detect potential pathogens, demonstrating proficiency in molecular biology techniques
- Performed DNA cloning and Gel Electrophoresis procedures, contributing to the analysis and visualization of genetic material
- Collaborated with neuroscientists on genetic testing for Amyotrophic Lateral Sclerosis (ALS) using In Vitro Diagnostic (IVD) devices, ensuring accurate and reliable test results
- Designed a research proposal by monitoring responses to culture media throughout the experiment, demonstrating analytical thinking and experimental design skills
- Prepared cultured media for experimental use, ensuring consistency and reliability in experimental conditions
- Assisted in an ALS research project, contributing to data collection, analysis, and documentation
- Maintained documents and presentations for the Journal Club Presentation, facilitating knowledge sharing and discussion among peers.
Volunteer (Assistant to Team Physician)
Northwestern Sports Medicine
08.2015 - 11.2015
- Actively contributed to the delivery of healthcare services during on-field sports injuries, demonstrating a commitment to providing timely and effective medical care
- Conducted evaluations and provided treatments for athletic injuries, utilizing knowledge of sports medicine principles and techniques to promote the well-being of athletes.
Education
Bachelor of Science - Biological And Physical Sciences (Pre-Med)
East West University
Chicago, IL03.2019
Skills
- Oncology Clinical Trial Management (Heme/Solid Tumors from Phase 1b - Phase 3)
- Regulatory Compliance
- Study Plans Development and Review
- Site Management and Monitoring
- Patient Recruitment and Enrollment
- Budget Reconciliation/CRO Invoice review
- USM management
- Audit management
- Vendor Management
- Risk Management
- Trend Analysis/Resolution
- Strong Communication, Interpersonal and Inclusive Leadership Skills
- Analytical and Critical Thinking
- Proficiency in Clinical Trial Management Systems (CTMS), IRT, eCOA and Electronic Data Capture (EDC) Platforms
Extracurricular Activities
- ToastMasters International Club Member
- Event Coordinator
- International Student Association Member
Professional achivements
- Received the "Values at Work" Award for the successful execution of an internal Investigational Brochure audit.
- Recognized with the "G.Thanks - Recognition Award" for:
1) Meeting DMC Snapshot timelines effectively.
2) Mentoring junior teammates to ensure their success.
3) Successfully leading Urgent Safety Measure related tasks.
Timeline
Clinical Trial Management (CTM) Associate - Oncology
Gilead Sciences,INC.
11.2021 - Current
Clinical Project Associate (Oncology)
Gilead Sciences,INC.
01.2021 - 11.2021
Clinical Lab Associate (Molecular Biology Lab)/ Lab Processor (Covid Samples)
Lifescan laboratories INC.
05.2020 - 09.2020
Clinical Lab Associate/ Lab Accessioner (Patient Sample Management - Cytology)
IDEXX laboratories (Illinois Veterinary lab)
10.2019 - 04.2020
Clinical Research Assistant Intern - Dermatology
Weisman Institute of Cosmetic Surgery
01.2019 - 10.2019
Research Assistant (Microbiology Department)
East West University
01.2018 - 11.2018
Volunteer (Assistant to Team Physician)
Northwestern Sports Medicine
08.2015 - 11.2015
Bachelor of Science - Biological And Physical Sciences (Pre-Med)
East West University