Sejal R. Patel
Innovative medical research professional with experience in the academic, pharmaceutical and biotech industries. Well versed in pre-clinical and clinical research, compliance and regulatory affairs. Sejal possesses a solid grounding in clinical, medical and pharmaceutical science with the ability to rapidly assimilate specific and detailed information driven by a willingness to acquire knowledge in new areas very quickly. Sejal is a Clinical Research Professional and currently a certified member of SoCRA. In addition to her medical expertise, she also has a strong interest in health informatics, management, leadership, quality improvement and operational skills.
HIGHLIGHTED SKILLS
• Extensive medical knowledge and training in medicine, clinical trials, health economic outcomes research, investigator-initiated sponsor trials, and company sponsored trial management
• Excellent therapeutic area knowledge in Transplant Medicine, Nephrology, and General Medicine.
• Able to demonstrate extensive experience, scientific acumen and strong communication skills
• Excellent communication skills; Highly articulate and persuasive during formal and informal presentations; able to synthesize complex, scientific ideas fluently to any audience
• Follows all internal policies and functions as scientific and clinical expert on current and future Pharm products in the area relevant to internal and external customers
• 8+ years of clinical and research experience in the areas of Psychiatry, Pediatric Solid and Liquid Tumors, Rare disease, Solid Organ and Bone Marrow Transplant Medicine, Diabetes, Immunology, Infectious Disease, Orthopedics, Transfusion medicine, Transplantation, Gastroenterology, Rheumatology, Cosmetic Science, Dermatology, and Ophthalmology.
PROFESSIONAL HISTORY
Mayo Clinic Hospital November 2018- Present
Clinical Studies Unit/Multi-Disciplinary Transplant Research
Certified Clinical Research Coordinator
• Independently coordinates complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines
• Collaborates with research team to assess feasibility and management of research protocols
• Ensures implementation of research protocols after IRB approval and provides information as appropriate
• Screens, enrolls, and recruits research participants
• Coordinates schedules and monitors research activities and subject participation
• Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems
• Manages, monitors, and reports research data to maintain quality and compliance
• Provides education/training for others within the department
• Performs administrative and regulatory duties related to the study as appropriate
• Manage Protocol Development and Maintenance Activities Responsibilities may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. blood collection kits, data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards
• Communication with study sites and/or federal agencies regarding study status changes
• Federal and Institutional Review Board (IRB) document preparation and submission
• Provides consultative expertise regarding regulatory and policy requirements
• Accurately applies investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements
• Participates in other protocol development activities and executes other assignments as needed
Clinical Fastrack May 2019- Present
Clinical Affairs Instructor
• Instructs and provides foundational and advanced role-based training for clinical research coordinators
• The course covers information that expands beyond but is directly connected to the Human Subjects Research (HSR) and Good Clinical Practice (GCP) practices
• Responsible for delivering basic clinical research coordinator training that organizations may use for onboarding new CRCs
• Included are the operational and regulatory essentials that clinical research coordinators need
• Also responsible for providing a basis for learners who will later move on to the advanced course
• In the course, I was required to give a deeper understanding of the clinical research coordinators role by exploring key operational, leadership, regulatory, and technical elements
Phoenix Children's Hospital January 2014- November 2018
Site Lead Clinical Research Coordinator- Phase I/II Oncology Studies
• Independently coordinated and was accountable for the overall administration of one or more clinical studies, typically requiring advanced-level knowledge and skills
• Responsible for coordination of a variety of research projects from pre-study implementation through study closure and works independently in the acquisition of specimens
• Managed the extraction and entry of patient data, maintenance of complete and accurate subject data, regulatory documentation, and analysis of data per protocol
• Responsible for assisting physicians with management of blood component and coagulation factor therapy in hematology transfusion medicine research trials
• Additionally, provided administrative / regulatory support (recruiting, interviewing and scheduling study participants, processing IRB and other regulatory documents) to specific clinical departments
• Provided mentorship and training to lower-level clinical research staff and/or support personnel, worked on departmental projects, and contributed to change implementation in the department
• Also involved in presenting clinical cases and problems in immunohematology and serving as an assistant to attending physicians regarding the choice of the best blood/ blood component therapy for their patients
• Attended investigator meetings and conferences as needed
Clinical Research Coordinator (Children's Oncology Group) January 2017- January 2018
• Assisted in the coordination of various research projects and supports the principal investigator and other clinical research support staff in the acquisition of specimens and extraction of data from patient charts
• Responsible for providing administrative / regulatory support by recruiting, scheduling study participants, processing IRB and other regulatory documents as needed in accordance with federal, state and regulatory agency requirements and specific institutional requirements
• Hematology/Oncology/Bone marrow transfusion study protocol submission to IRB
• Consenting potential subjects/participants for research studies: Working with Children's Oncology Group
Clinical Research Associate (Gastroenterology/Rheumatology Studies) October 2015- January 2017
• Maintained coordination of various research projects and supports the principal investigator and other clinical research support staff in the acquisition of specimens and extraction of data from patient charts
• Provided administrative /regulatory support by recruiting, scheduling study participants, processing IRB and other regulatory documents as needed in accordance with federal, state and regulatory agency requirements and specific institutional requirements
• Study protocol submission to IRB
• Consenting potential subjects/participants for research studies
• Worked with quality improvement network registry studies such as ImproveCareNow and PR COIN
Bioscreen Clinical Services February 2013- October 2015
Clinical Project Manager/Trial Liaison
• Planned, developed and managed the safety and efficacy of research studies
• Supervised Research Assistants and other support staff in carrying out research studies according to protocol. Worked closely with VP of clinical services and/or other Principal Investigators to ensure the research studies are conducted under company SOP's and Good Clinical Practice guidelines
• Participated in and coordinated the planning, development and implementation of study protocols, logistical procedures, and operating systems
• Generated study protocols, interim reports, and final reports for study sponsors
• Responsible for collection, interpretation of data results, and analyzing data
• Responsible for serving as a Sub-investigator in dermatology and ophthalmology grading and testing for safety and tolerance
Bioscreen Clinical Services January 2011- February 2013
Consulting Investigator
• Acted as a conduit of information about new research developments, clinical trial activities and therapeutic approaches
• Responsible for cultivating and maintaining relationships with academic researchers and leaders, attending conferences and talks, presenting information to pharmaceutical product teams and marketing new therapeutic products to physicians and other healthcare professionals
Mayo Clinic May 2011- May 2012
Postdoctoral Research Trainee-Nephrology/Transplant Medicine
• Employed a broad knowledge of principles, practices, and procedures in Nephrology and transplant medicine to plan, design, and conduct research/ present findings
• Carried out complex assignments requiring the development of new or improved techniques
• Responsible for action involving a liaison capacity with various department, divisions, and organizations
Educational Experience
MD, Medical University of Silesia Katowice, Poland 2002-2006
ECFMG Board Certified
BS, Psychology, Pre-Medicine University of Arizona Tucson, AZ 1999-2001
University of Kansas Lawrence, KS 1997-1999
Affiliations
Donate Life Arizona volunteer (2015 - present)
Society of Clinical Research Associate member- SoCRA certified CCRP (2020-present)
UNOS/OPTN Patient Affairs Ambassador and Committee Member (2021-present)
Medical Science Liaison Society member (2014-present)
Feed the Starving Children volunteer (2018-present)
ASU Stem Summer Research Experience Judge (May 2019)
Mayo Employee Resource Group member (eMerging Leaders, GLOW, American Asian)
Clinical Practice, Interests, And Accomplishments
• Pediatric Oncology, Solid Organ Transplant Research, Nephrology Research, Gastroenterology Research, Rheumatology Research, Immunology Research, Infectious Disease Research, Endocrinology Research, Rare Disease Research- Langerhans Cell Histiocytosis
• Interests in Biomedical Research, Clinical Informatics, STEM
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