Clinical Research Patient Care
Resume:
LORI DUNIGAN-JONES
*** * *** ******, **********, IN 47356
PROFESSIONAL SUMMARY
Experienced designer and dedicated research coordinator with a Master’s of Clinical Research Management/Regulatory Science Program. I have over ten years of knowledge and experience in creating and maintaining regulatory and/or SOP’s as well as hands-on experience in patient care within a hospital and clinical setting. I have worked diligently with sponsors, CRO’s, CRM’s, and CRA’s to guarantee study success. I am very capable of managing with the ability to prioritize a project with little or no supervision. Proven ability to effectively work well with others as well as having excellent interpersonal and communication skills while offering meticulous attention to detail. I have a lot to offer while being open to change and the opportunity to expand upon that experience and knowledge.
EXPERIENCE
Ascension St. Vincent Hospital, Indianapolis, IN November 2022-present
Clinical Research Coordinator
Ascension St. Vincent Cardiovascular Institute of Indiana Research Department
• Initiates and conducts protocol review, evaluations, study design, and risk assessments within the cardiovascular clinical research studies.
• Participates in creating study budget and negotiations.
• Develops informational materials for recruitment of subjects; monitors enrollment goals and modifies recruitment strategy as needed.
• Oversees and ensures compliance with creation/maintaining of regulations, SOP’s, including organizing electronic files and/or filing of regulatory documents appropriately; prepares and submits IRB documents; prepares regulatory documents for sponsor.
• Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and conducting interviews; performs subject interviews and assessments for data required by protocol(s).
• Follows up on study documentation with necessary PI’s, study participants, lab personnel, etc.
• Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators.
• Stays up to date with the knowledge of regulatory affairs and/or issues.
IU School of Medicine, Indianapolis, IN November 2021-November 2022
Clinical Research Coordinator
IUSOM Gastroenterology & Hepatology Department
• Initiates and conducts protocol review, evaluations, study design, and risk assessments of liver, HIV, and diabetes clinical research studies.
• Participates in creating study budget and negotiations.
• Develops informational materials for recruitment of subjects; monitors enrollment goals and modifies recruitment strategy as needed.
• Oversees and ensures compliance with creation/maintaining of regulations, SOP’s, including organizing electronic files and/or filing of regulatory documents appropriately; prepares and submits IRB documents; prepares regulatory documents for sponsor.
• Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and conducting interviews; performs subject interviews and assessments for data required by protocol(s).
• Follows up on study documentation with necessary PI’s, study participants, lab personnel, etc.
• Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators.
• Stays up to date with the knowledge of regulatory affairs and/or issues.
IU Health January 2011-May 2022
Clinical Research Technician/Specialist
IU Health Methodist Hospital, Indianapolis, IN August 2019 – Nov 2022
• Recruiting and consenting study participants based on our BioBank system and criteria.
• Creating remnant and future order lab orders for study participants. Manage research study email account and correspond daily with patients, and other clinical research coordinators.
• Scheduling appointments for patient lab work, pre-register, and meet the patient at the front entrance and walk back to labs to be completed.
• Managed and recruited for Covid-19 clinical research study; patient screening including completed consent and lab work. Creating/maintaining documents and database for the study as well as in charge of follow-up and schedule appointments with patients for continue lab work throughout their recovery.
• Leading weekly team meetings and preparing the agenda for the team.
Surgical Adult Unit Secretary/PCT
IU Health Ball Memorial Hospital, Muncie, IN August 2018 - August 2019
• Drawing labs, performing EKG’s, and prepped of each patient before surgery.
• Analyzed all patient information is accurate and all information is complete within a patient’s chart.
• Performed the duties of a technician as well and this would consist of prepping the patient as well as giving quality care in PACU and Secondary.
Resource Pool PCT - unit secretary & patient care technician – PRN
IU Health Ball Memorial Hospital, Muncie, IN January 2011 – May 2022
• Daily tasks performed include taking vital signs, lab draws, EKG's, patient care, dressing changes, performing in/out catheter, anchoring foleys, changing/empty of drains and/or colostomy’s and anything else needed for our team to be successful in our patients care while at our facility.
• Inputting information into patient medical records.
• Assisting with daily activities like helping a patient bathe, dress, eat, walk, and get in and out of bed.
Product Design
Delco Remy, Anderson, IN June 1998 - November 2008
• Creation/maintaining the quality and compliancy documents per ISO 9000 regulating standards as well as SOP’s for the engineering design and manufacturing departments.
• Utilizing state-of-the-art software tools and methods and supporting technical teams and/or writings to capture and publish analysis, practices, labeling/instructions, as well as guidelines.
• Perform and coordinate all work on assigned projects.
• Design of transmission and engine parts.
• Ability to communicate production timelines with overseas manufacturing plants concerning prototype parts.
Product Design
Delta Faucet Company, Indianapolis, IN January 1988-June 1998
• Creation/maintaining the quality and compliancy per ISO 9000/Six Sigma regulating standards as well as SOP’s for the engineering design and manufacturing departments.
• Utilizing state-of-the-art software tools and methods and supporting technical teams and/or writings to capture and publish analysis, practices, labeling/instructions, as well as guidelines.
• Perform and coordinate all work on assigned projects.
• Design, and manufacturing of faucets, instruction sheets, packaging, marketing/advertisement.
• Prototype concept and research completed on new designs.
• Project management, cost analysis, and timelines created/maintained throughout projects.
• Team-lead for biweekly meeting with the design department and manufacturing plant.
• Redesign of the faucet/parts for reducing manufacturing costs and to be able to use existing tooling.
EDUCATION
Arizona State University May 2021- August 2022
Master of Science in Clinical Research Management & Regulatory
Anderson University, Anderson, IN August 2012-May 2014
Bachelor of Arts
Ivy Tech Community College, Anderson, IN May 2010-May2012
Associates of General Studies
ITT Technical Institute, Indianapolis, IN June 1980- June 1982
Associates of Arts in Architectural Engineering
SKILLS
Experience in new clinical research study start-up
Experience & capability to work efficiently/effectively with the IRB, CRO, & Sponsor per protocol detail
Regulatory protocol, source document and standard operating procedures /workflow development & maintenance
Creation of and maintaining the quality and compliance of all documentation within the research department
Quality Assurance & Management within study protocols, procedures, documentation, and recruitment
The ability to report and validate source documents per study protocol
Ability to communicate effectively with study sources such as the CRA, CRM, as well as the study Sponsor
Applications: RedCap, Cerner, OTTR, Oncore, Athena, Sovera, and Sunrise
Creation of Technical Writing, Instruction, & Illustration documentation
Good clinical practices, IRB, NIH, FDA,
ISO 9000 Regulatory Standards & Six Sigma Regulatory Standards
Applications: Microsoft 365, Adobe Pro, ProEngineer, and AutoCad
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