Elizabeth Marie Smith
Minneapolis
Summary
Diligent clinical research coordinator with comprehensive background in coordinating clinical research studies. Successfully managed multiple clinical trials from initiation to closeout, ensuring adherence to regulatory guidelines. Demonstrated ability to effectively communicate with cross-functional teams and maintain meticulous documentation.
Overview
26
26
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator I, Clinical Trials Office
University of Minnesota
08.2025 - Current
- Lead coordinator for a biobanking study to collect multiple types of solid tumors for current and future research.
- Developed and maintained study documentation, including informed consent forms and case report forms.
- Collaborated with cross-functional teams to streamline trial processes and improve efficiency.
- Monitored data collection procedures for accuracy, consistency, and regulatory adherence.
- Coordinated clinical trials, ensuring compliance with regulatory standards and protocols.
- Managed participant recruitment and retention strategies to enhance study enrollment.
Clinical Research Coordinator I, Bone Marrow Transplant
Children’s Hospital Los Angeles
07.2023 - 08.2025
- Coordinate investigator-initiated and sponsored trials for Phase I, II, and III studies.
- Use KIDS electronic medical records for screening, eligibility, data, and source acquisition.
- Organize consent conferences between investigators, subjects, parents, and interpreters depending on the needs of the participants.
- Obtain consent/permission/assent for non-therapeutic studies.
- Ensure consent and eligibility process is performed and documented per federal, sponsor, and institutional requirements.
- Coordinate patient study visits and associated study procedures (e.g., specimen collection and shipment, laboratory tests, infusions, study-specific assessments, etc.).
- Complete case report forms on paper and electronic data capture systems.
- Coordinate the delivery and administration of investigational drugs.
- Prepare and submit applications, amendments, continuing reviews, and reportable events to the Institutional Review Board.
- Prepare and submit regulatory compliance documents to study sponsors.
- Maintain subject research charts and study regulatory binders.
- Crosstrain and serve as study backup for other study coordinators.
- Submit invoices for studies via OnCore.
Representative, Reports Compliance
Directors Guild of America
07.2017 - 02.2019
- Monitors department email for guild compliance reports, i.e., deal memos, weekly work lists, and any internal/external correspondence, forwarding them to appropriate personnel as necessary.
- This includes parsing all deal memos into the system with timeliness and accuracy.
- Process deal memos as they are parsed into the system with great attention to detail concerning pay and time guarantees and code for revisions as necessary.
- Enter DGC permits and crew into their appropriate projects.
- Ensure all information detailed in projects — crew, categories, titling — is accurate and current.
- Upload all supporting documentation to the guild system.
- Takes on new tasks as necessary to ensure departmental success.
- Communicate with colleagues both in and outside of the department and guild effectively and respectfully.
- Practice utmost discretion to ensure the privacy of all guild members.
Data Coordinator, Leukemia Research
M.D. Anderson Cancer Center
07.2005 - 09.2009
- Retrieve study data from patient records and outside institutions for CRF completion. This includes eCRFs, protocol in AECS, QDS, EDC, and InForm.
- Develop and maintain systems for controlling paper flow for protocols and hospital policies, including records of surgery and pathology information.
- Prepare SAE forms with supporting documents for PI signature and sponsor submission.
- Develop and maintain databases for the collection of research data.
- Maintain schedules for timely submission of all grant data.
- Assist in the preparation of information and reports for grant submission.
- Responsible for completing data forms, dosimetry films, treatment records, surgery, and pathology information.
- Act as a liaison with physicians, research nurses, pharmaceutical monitors, and other personnel.
- Maintain contact with other institutions participating in studies and coordinate all data, which includes attending planning clinics, site initiation meetings, and facility tours.
Pharmacy Technician, Investigational Pharmacy Services
M.D. Anderson Cancer Center
09.1999 - 06.2005
- Audit and maintain an adequate inventory of the investigational drug supplies in assigned satellite pharmacies.
- Return investigational drugs that have expired from the satellite pharmacy to the Control area and the respective protocol sponsor.
- Receive shipments of investigational drugs into inventory upon arrival.
- Prepare and mail investigational drugs to patients, when necessary, under the guidance of an investigational drug pharmacist.
- Enter investigational drug transactions into the ePIC drug accountability system in the assigned pharmacy satellite dispensing area and the Control area.
- Collect materials (i.e., labels, vials, etc.) from the various pharmacy satellites to satisfy specific sponsor requirements.
- Act as the responsible contact person in the Investigational Pharmacy during the evening or weekend shift to rectify problems where possible or to determine how to utilize other Investigational Pharmacy staff to resolve problems where necessary.
- Demonstrate excellent interpersonal skills; establish and maintain the respect and confidence of co-workers, both inside and outside of the Division of Pharmacy, working effectively and professionally with a variety of individuals including administrators and management staff, pharmacists, physicians, technologists, and other institutional employees.
- Coordinate monitor/auditor visits and collect all necessary documents and supplies for the visit.
- Contribute to the educational efforts through the development and provision of internal and external professional and lay education.
Education
High School -
J. Frank Dobie High School
Houston, Texas05.1997
Skills
- Good clinical practices
- Electronic data capture
- Adverse event reporting
- Informed consent process
- Investigational product management
- Clinical trial management
- Participant screening
- Adverse event tracking
- Teamwork and collaboration
- Patient care coordination
- Medical terminology
- Regulatory compliance
Certification
- Good Clinical Practice and Human Research Subject Protections Certification, CITI Program – EXP Aug 2028
- BLS Provider, American Heart Association – EXP Feb 2027
Timeline
Clinical Research Coordinator I, Clinical Trials Office
University of Minnesota
08.2025 - Current
Clinical Research Coordinator I, Bone Marrow Transplant
Children’s Hospital Los Angeles
07.2023 - 08.2025
Representative, Reports Compliance
Directors Guild of America
07.2017 - 02.2019
Data Coordinator, Leukemia Research
M.D. Anderson Cancer Center
07.2005 - 09.2009
Pharmacy Technician, Investigational Pharmacy Services
M.D. Anderson Cancer Center
09.1999 - 06.2005
High School -
J. Frank Dobie High School
Similar Profiles
Josh DayJosh Day
Parking Attendant at University of MinnesotaParking Attendant at University of Minnesota
Addison EernisseAddison Eernisse
RecWell Employee at University of MinnesotaRecWell Employee at University of Minnesota
Jack PanichelliJack Panichelli
Investment Banking Club at University of MinnesotaInvestment Banking Club at University of Minnesota
Dustin HomseyDustin Homsey
Owner/Operator at Southside Homsey & Homsey LLC.Owner/Operator at Southside Homsey & Homsey LLC.
Isabelle MeyerIsabelle Meyer
Server at Baraboo Burger CompanyServer at Baraboo Burger Company