Kim Walker
Stafford,TX
Summary
Proficient Research Coordinator with 20 years in clinical research successful at managing phase I -IV research trials. Proficient many therapeutic areas. Knowledgeable about coordinating patient information, laboratory samples, regulatory submissions and compliance documents. Highly organized and thorough with good planning and problem-solving abilities. Knowledgeable at recognizing clinical values and abstract data from source documents. Uses analytical skills to identify data or patient safety issues. Work well independently and with others utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
16
16
years of professional experience
Work History
Senior Research Coordinator
Texas Heart Institute
04.2021 - Current
- Ma patient recruitment, informed consent process and data entry to support trial objectives.
- Prepared documents, reports, and presentations detailing results and conclusions.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Reviewed referral information and kept track of intakes from various referral sources.
- Complied with research protocols by providing ongoing quality control audits.
- Improved participant recruitment strategies, leading to a higher number of qualified candidates for studies.
- Maintained strict adherence to ethical guidelines in all aspects of research coordination, ensuring study integrity and compliance with regulations.
- Enhanced collaboration among team members through clear communication and regular meetings.
- Gathered, processed, and shipped lab specimens.
- Oversaw research projects focused on [Area] with teams of up to [Number] members and budgets of $[Amount] or more.
Coordinator Clinical Studies
MD Anderson
11.2017 - 03.2021
- Screen potential patients for studies,
- Obtain and ensure that informed consent is properly, signed, off by PI in epic in a timely manner.
- Document the consent process in epic.
- Obtain insurance approval for research participants.
- Schedule study related testing and follow-up visits outlined in.
- Record adverse events and reported SAEs to sponsor in the required time protocols frame per protocol requirements.
- Conduct weekly meetings with PI and research team member to discuss study progress, and issues.
- Register study participants inclusion/exclusion criteria in Core data system.
- Upload study mediation treatment plan orders in patient epic medical records
- Enter and answer queries in data system in a timely manner.
- Documented AEs,Deidentified, submitted SAEs to sponsor and MD Anderson Investigational new drug office according to reporting polices.
Clinical Research Coordinator
Research Concept
10.2016 - 11.2017
- Monitored unit budget to meet financial objectives for spend rate and funding.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Reduced data entry errors by implementing stringent quality control measures throughout the study lifecycle.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Maintain effective communication with patients, physicians, company representative and monitor for each research protocol. Interact with all departments involved in each research protocol, including education of nursing staff or other participants
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Worked effectively in fast-paced environments.
- Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
Research Coordinator
University Of Texas Health Science Center
06.2012 - 08.2016
- Coordinate research. projects according to research guidelines.
- Coordinate clinical trials in compliance with federal good clinical practice guidelines.
- Coordinate daily administrative activities of multiple research projects.
- Conduct physical assessments research participants.
- Consenting of research candidates regarding the overall research study including risks, benefits of the research protocol of interest.
- Maintain continuous contact with research subjects to ensure subject compliance and that follow-up requirements are met.
- Work with Principal Investigators and research team to keep them informed of all new developments and progress of the protocols.
- Frequent interaction with the IRB while submitting all necessary correspondence including but not limited to submission of new protocols, periodical progress reports, yearly project renewals, adverse events, protocol changes, and sponsor correspondence.
- Correspondence with project sponsors about daily maintenance of the research trials.
- Dispense study drug and maintain drug and device accountability logs.
- Maintain drug temp logs
Senior Clinical Research Coordinator
Red Oak Psychiatry Associates
04.2011 - 06.2016
- Assist with investigational study selection and project negotiation, including initial site/sponsor correspondence, budget preparation, and regulatory document preparations for protocol, informed consent, and inclusions for IRB submission.
- Utilize Standard Operating Procedures (SOP), Good Clinical Practices (GCP) and International Committee on Harmonization (ICH) guidelines.
- Ongoing management of study review process according to site/sponsor/IRB guidelines.
- Responsible for patient screening, recruitment, consenting and enrollment for ongoing clinical research projects, including all follow-up management and case report form completion.
- Maintain source documentation and drug/device accountability.
- Conduct staff and unit in-services prior to implementation of new research trials.
- Arrange and conduct physician meetings to discuss research studies.
- Point of contact for physicians on all new and potential research subjects.
- Collect, process and ship lab specimens per ITIA requirement.
- Performed study related procedures, such as ECG's, vital signs, and questioners
- Contributed to the successful completion of numerous studies by coordinating all aspects of trial initiation, execution, and close-out activities.
- Ensured compliance with regulatory requirements by conducting thorough audits of study documents and procedures.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Reviewed referral information and kept track of intakes from various referral sources.
- Proved successful working within tight deadlines and a fast-paced environment.
Research Coordinator
Research Specialist Of Texas
02.2008 - 02.2011
- Recruit, and Screen patients for studies, following protocols established inclusion/exclusion criteria.
- Obtain informed consent is properly obtained, signed, and documented.
- Collect, process and ship lab specimens per ITIA requirement. Schedule study related procedures and conducted follow-up visits per study protocols.
- Performed study related procedures, such as ECG's, vital signs, and questioners.
- Record adverse events and reported SAEs to sponsor in the required time frame per protocol requirements.
- Prepared and participated in study start up, sponsor monitor visits and close out visits.
- Entered and answered queries in data system.
- Created and amended source document.
- Attended investigator meetings.
- Train and manage new coordinators.
- Create source documents for protocols
- Prepare and participate in FDA and sponsor inspections.
- maintain drug accountability records, shipping and receiving
- Prepare and participate in FDA and sponsor inspections.
Education
Bachelor of Science - Nursing
Western Governors University
Salt Lake City, UT01.2026
Associate of Applied Science -
Houston Community College
Houston, TX12.2023
Skills
- Informed consent
- Phlebotomy
- Schedule Coordination
- Medication Dispensing
- Data organization
- Records Maintenance
- Patient recruitment
- Troubleshooting
- Verbal Communication
- Multitasking
- Written Communication
- Attention to Detail
- Microsoft Word
- MS Office
- Analytical Thinking
- Participant screening
- Good Clinical Practices
- Scheduling proficiency
- Specimen handling
- Feasibility assessments
- Research SOPs understanding
- EDC
- Specimen collections
- Team Management
- Relationship Building
- Flexible and Adaptable
- Problem-Solving
- CPR
- Computer Skills
- Organization and Time Management
Timeline
Senior Research Coordinator
Texas Heart Institute
04.2021 - Current
Coordinator Clinical Studies
MD Anderson
11.2017 - 03.2021
Clinical Research Coordinator
Research Concept
10.2016 - 11.2017
Research Coordinator
University Of Texas Health Science Center
06.2012 - 08.2016
Senior Clinical Research Coordinator
Red Oak Psychiatry Associates
04.2011 - 06.2016
Research Coordinator
Research Specialist Of Texas
02.2008 - 02.2011
Bachelor of Science - Nursing
Western Governors University
Associate of Applied Science -
Houston Community College
Similar Profiles
Selena SandovalSelena Sandoval
Cardiovascular Perfusion Student at Texas Heart InstituteCardiovascular Perfusion Student at Texas Heart Institute
Heather StonerHeather Stoner
Coordinator at Texas Heart InstituteCoordinator at Texas Heart Institute
Phillip HernandezPhillip Hernandez
Nuclear Medicine Manager at Texas Heart InstituteNuclear Medicine Manager at Texas Heart Institute
Stephanie CantuStephanie Cantu
Customer Service Representative at Moderno Porcelain WorksCustomer Service Representative at Moderno Porcelain Works
Jacinda RangelJacinda Rangel
Intern, Fort Bend County Youth Employment Program at Justice of the Peace, Precinct 4, Judge Keisha T. SmithIntern, Fort Bend County Youth Employment Program at Justice of the Peace, Precinct 4, Judge Keisha T. Smith