Clinical Research Coordinator II

LORI DUNIGAN-JONES

Email : ********@***.*** / Phone : 765-***-****

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 SOPs 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

UAB, University of Alabama at Birmingham, Birmingham, AL September 2023-present

Clinical Research Coordinator ll

O’Neil Comprehensive Cancer Center, Office of Clinical Trials

Serves as a liaison with medical staff, University Department, ancillary departments and/or satellite facilities. Organizes patient enrollment planning. Conducts quality assurance activities. Compiles and analyzes data. Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected.

Coordinates patient care and/or patient follow-up functions of the clinical study including planning and developing related activities. Arranges access to study medications, including authorization for prescriptions. Employs strategies to maintain recruitment and retention rates.

Prepares and submits multiple levels of research documentation (i.e. IRB, IND, or FDA submissions, educational materials, reports, grant renewal reports, and study forms).

Manages investigational products (IP). Employs the required system (including personnel) for handling, dispensing, and documenting IP for sponsored protocols.

In conjunction with Investigators, plans and implements the clinical protocol’s goals and objectives. Compiles, edits and proofs written reports for both internal and external administrative offices. Provides data for the creation of the study budgets as needed.

Completes Case Report Forms (CRF) according to protocol. Assists with development of standard operating procedures (SOPs) for data quality assurance.

Performs vendor analysis and equipment configuration as needed. May perform a variety of medical procedures.

Under the oversight of the Investigator, develops protocols, identifies efficiencies and improves processes. Serves as a mentor to junior staff, including student assistants. Arranges multidisciplinary evaluations.

Maintains compliance with federal, state and accrediting agencies (sponsors).

Maintains any required documentation.

Manages site supplies as needed.

Performs other duties as assigned.

Ascension St. Vincent Hospital, Indianapolis, IN November 2022-August 2023

Clinical Research Coordinator l

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, SOPs, 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, SOPs, 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 EKGs, 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 SOPs 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 SOPs 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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