Summary
Overview
Work History
Education
Skills
Certification
Publications
Timeline
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Sejal R. Patel

Mesa,USA

Summary

Medical Research Physician | Medical Science Liaison | Researcher
Certified SoCRA professional with cross-sector experience in academia, pharma, and biotech. Expertise in oncology, nephrology, cardiology, hepatology, infectious disease, and immunology, with a focus on transplant diagnostics, immunosuppressive therapies, regenerative treatments, and clinical strategy. Proven ability to advance patient outcomes and lead cross-functional teams through evidence-based innovation.

Overview

15
15
years of professional experience
1
1
Certification

Work History

Research Collaborator-Nephrology/Transplant Medicine (volunteer)

Mayo Clinic
04.2024 - Current
  • Collaborative teamwork in Nephrology and Hepatology Transplant Medicine research to plan, design, and conduct research/ present findings.
  • Duties include data abstraction, data analysis, publication, regulatory compliance, technical skills, project management, contribution to abstracts, manuscripts, research papers, presentations, and reports for peer-reviewed journals and conferences.

Clinical Science Liaison (MSL)- Western US Territory

ProKidney
03.2023 - Current
  • Maximizes site performance and site engagement in clinical studies for patients with CKD and Type II diabetes involving immunologic therapy to slow down kidney disease
  • Leveraging strong clinical operational and therapeutic expertise to support the execution of clinical studies.
  • Responsible for the planning, initiation, coordination, and management of all monitoring and monitoring-related activities as well as supervision of all site-related activities to ensure compliance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and regulatory requirements.
  • Engages with clinical sites to develop, build, and maintain strong relationships with investigators/staff that will ensure high- quality investigative sites to support clinical development programs.
  • Collaborate with internal and external stakeholders as well as third-party vendors.
  • Provide operational support to the CPM/Sr CPM to deliver the study within planned timelines and according to required standards of quality and compliance.
  • Evaluate, screen, and develop high-quality investigative sites to support clinical development programs. Interface with KOLs with close cooperation on key science-related questions regarding the study trial.
  • Assistance with CEO and VP to build Medical Affairs and Marketing team from ground up in a start-up environment, working alongside stakeholders to align scientific strategy with commercialization goals.

Clinical Science Liaison-Western US territory

Eurofins Transplant Genomics
10.2023 - 03.2025
  • Effectively and accurately presented and detailed Transplant Genomics’ genetically-based science and clinical data to hepatologists and nephrologists, both in small group discussions and formal group presentations; Key contacts with Hepatologists, Nephrologists, and Infectious Disease KOLs
  • Developed and maintained strong relationships with KOLs, clinical decision-makers, and other healthcare professionals within the expanded territory
  • Worked both independently and collaboratively with sales, marketing, sales operations, and client services to implement commercial development strategies in the designated market(s) and achieve established goals
  • Collaborated with Commercial Leadership in the implementation of clinical strategic initiatives for the team
  • Assisted Clinical Trials team in the enrollment and management of hospitals and subjects for clinical studies
  • Collaborated with the commercial team to develop and manage customer advocates and KOLs within the transplant space
  • Maintained complete records of activities and provided updates to management on insights, key issues, and competitive market information
  • Attended transplant conferences (including AASLD, WTC, ASN, ATC) and represented Transplant Genomics to uncover and support collaboration and business opportunities
  • Attended Mayo Clinic Hepatology mini conferences with Mayo hepatologists and visiting guests
  • Interfaced with KOL collaborators (hepatologists and nephrologists) to develop, publish, and present results at conferences.
  • Assisted in new hire training and continuing education initiatives for the commercial organization and fellow MSLs
  • Held various meetings and presentations with Houston Methodist Hospital, Mayo Clinic Arizona, and Mayo Clinic Rochester.

Senior Clinical Program Coordinator

Mayo Clinic
02.2022 - 10.2023
  • Oversaw the Research Center or Program, which serves as the research administrative base for a small to medium-sized research program(s) involving multicenter clinical trial/research groups with national/international participation
  • Provided leadership, management, and direction, and is responsible for the operation of the program within the designated Research Center or Program
  • Coordinated resources and workloads to achieve objectives and strategies
  • Worked with Scientific and Administrative leadership in the development of strategic plans, programmatic budgets, and process improvements
  • Managed partnerships with national/international consortium or program members
  • Worked collaboratively with federal and/or industry sponsors and agencies for items related to the Research Center or Program
  • Participated in grant renewal processes and progress reports
  • Initiated and maintained positive working relationships with internal (e.g., IRB, Compliance Office, MCA, MCF, etc.) and external customers (e.g., FDA, NIH, OHRP, etc.). Manages projects and serves as a primary resource for issues and communications relating to the Research Center or Program
  • Performed duties independently and initiated judgments in handling a variety of programmatic issues
  • Maintained broad-based management or project management experience to coordinate a wide range of activities, including ongoing knowledge of clinical research, research programs, data management, and computer/related systems. Strong leadership, team building, and problem-solving skills, as well as the ability to work collaboratively with multiple disciplines, i.e., physician, administrative, supervisory, and allied health staff, and external agencies.
  • Worked closely with the cardiologists, electrophysiologists, lipidologists, and cardiothoracic surgeons to help push research trials further within the department with investigator-initiated trials funded by pharmaceutical sponsors.

Clinical Affairs Instructor/Teacher

Clinical Fastrack (Per Diem)
05.2019 - 10.2023
  • Instructs and provides foundational and advanced role-based training for clinical research coordinators
  • Present and educate via PowerPoint presentation- 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 coordinator's role by exploring key operational, leadership, regulatory, and technical elements

Research Coordinator

Mayo Clinic Hospital
11.2018 - 01.2021
  • 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, particularly on studies focused on cardiology, hepatology, and nephrology etiologies that were leading to transplant and post-transplant.
  • Focus on sponsor and investigator-initiated studies in all relevant rare and unmet disease areas.
  • Collaborate with the research team to assess the 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 included: 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

Site Lead Clinical Research Coordinator- Phase I/II Oncology Studies

Phoenix Children's Hospital
01.2014 - 11.2018
  • Independently coordinated and was accountable for the overall administration of one or more clinical studies, typically requiring advanced-level knowledge and skills
  • Responsible for the 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 the management of blood components and coagulation factor therapy in hematology, transfusion medicine research trials
  • Administrative/regulatory support provided (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
  • 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)
01.2017 - 01.2018
  • Assisted in the coordination of various research projects and supported the principal investigator and other clinical research support staff in the acquisition of specimens and the 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 by federal, state, and regulatory agency requirements and specific institutional requirements
  • Hematology/Oncology/Bone marrow transfusion study protocol submission to IRB.
  • Solid Tumors primarily of Liver, Kidney, and Lung origin
  • Consenting potential subjects/participants for research studies: Working with Children's Oncology Group

Clinical Research Associate (Gastroenterology/Rheumatology Studies)
10.2015 - 01.2017
  • Maintained coordination of various research projects and supported 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 by federal, state, and regulatory agency requirements and specific institutional requirements
  • Studies involving Biliary Atresia, Alpha-1 Antitrypsin Deficiency, Inflammatory Bowel Disease, and Hepatitis C
  • Study protocol submission to the IRB
  • Consenting potential subjects/participants for research studies
  • Worked with quality improvement network registry studies such as ImproveCareNow and PR COIN

Clinical Project Manager/Trial Liaison/Medical Affairs Liaison

Bioscreen Clinical Services
02.2013 - 10.2015
  • 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 the VP of clinical services and/or other Principal Investigators to ensure the research studies are conducted under company SOPs and Good Clinical Practice guidelines
  • Participated in and coordinated the planning, development, and implementation of study protocols, logistical procedures, and operating systems
  • Responsible for collecting, interpreting data results, and analyzing data
  • Responsible for serving as a Sub-investigator in dermatology and ophthalmology grading and testing for safety and tolerance
  • Relaying and providing clinical knowledge gained from trials to healthcare professionals and key thought leaders
  • Focus on communications within the company with patients, medical professionals, and sponsors.
  • Bridge between industry and providing scientific and clinical support for commercial products, and serve as the medical face of the company.
  • Generated study protocols, interim reports, and final reports for study sponsors

Consulting Investigator

Bioscreen Clinical Services
01.2011 - 02.2013
  • 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.

Postdoctoral Research Trainee-Nephrology/Transplant Medicine

Mayo Clinic
05.2011 - 05.2012
  • 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 actions involving a liaison capacity with various departments, divisions, and organizations

Education

ECFMG (Educational Commission for Foreign Medical Graduates) Board Certified Physician -

Instructor in Health Services Research - undefined

Mayo Clinic College of Medicine and Science
08.2025

MS - Molecular Pharmacology and Experimental Therapeutics

Mayo Clinic Graduate School of Biomedical Sciences
01.2024

MS - Medical Doctorate

Medical University of Silesia Katowice
01.2006

BS - Psychology, Pre-Medicine

University of Arizona
Tucson, AZ
01.2001

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University of Kansas
Lawrence, KS
01.1999

Skills

  • Positive attitude
  • Teamwork and collaboration
  • Organized and efficient
  • Problem-solving
  • Public speaking
  • Decision-making
  • Relationship building
  • Reliability and punctuality

Certification

• FASN (American Society of Nephrology)- Fellow (2025-present)


Society of Clinical Research Associate member- SoCRA certified CCRP (2020- present)

Publications

  • Time-Dependent Impact of Positive Peripheral Blood Gene Expression Profile Results on Renal Function: Interim Report of the TRULO Study
  • Impact of Transplant Vintage on Associations Between Positive Peripheral Blood Gene Expression

Timeline

Research Collaborator-Nephrology/Transplant Medicine (volunteer)

Mayo Clinic
04.2024 - Current

Clinical Science Liaison-Western US territory

Eurofins Transplant Genomics
10.2023 - 03.2025

Clinical Science Liaison (MSL)- Western US Territory

ProKidney
03.2023 - Current

Senior Clinical Program Coordinator

Mayo Clinic
02.2022 - 10.2023

Clinical Affairs Instructor/Teacher

Clinical Fastrack (Per Diem)
05.2019 - 10.2023

Research Coordinator

Mayo Clinic Hospital
11.2018 - 01.2021

Clinical Research Coordinator (Children's Oncology Group)
01.2017 - 01.2018

Clinical Research Associate (Gastroenterology/Rheumatology Studies)
10.2015 - 01.2017

Site Lead Clinical Research Coordinator- Phase I/II Oncology Studies

Phoenix Children's Hospital
01.2014 - 11.2018

Clinical Project Manager/Trial Liaison/Medical Affairs Liaison

Bioscreen Clinical Services
02.2013 - 10.2015

Postdoctoral Research Trainee-Nephrology/Transplant Medicine

Mayo Clinic
05.2011 - 05.2012

Consulting Investigator

Bioscreen Clinical Services
01.2011 - 02.2013

Instructor in Health Services Research - undefined

Mayo Clinic College of Medicine and Science

MS - Molecular Pharmacology and Experimental Therapeutics

Mayo Clinic Graduate School of Biomedical Sciences

MS - Medical Doctorate

Medical University of Silesia Katowice

BS - Psychology, Pre-Medicine

University of Arizona

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University of Kansas

ECFMG (Educational Commission for Foreign Medical Graduates) Board Certified Physician -

Sejal R. Patel