Summary
Overview
Work History
Education
Skills
Timeline
Generic

Heather Keaney

N Ridgeville,OH

Summary

Highly skilled research professional with a strong background in leading teams and managing complex projects. Proven track record in enhancing clinical trial coordination and fostering cross-functional collaboration. Consistently adapts to evolving project requirements. Renowned for problem-solving abilities, excellent communication skills, and results-driven mindset.

Overview

11
11
years of professional experience

Work History

Research Supervisor

Cleveland Clinic Taussig Cancer Institute
04.2024 - Current
  • Supervises and coordinates the organization and compliant execution of multiple research projects of a specialized research program with the proper allocation of resources and adherence to research protocol requirements.
  • Assures quality and safe patient care, anticipating and resolving patient care and study issues by serving as a liaison between investigators, research personnel, outside study personnel and central research administration offices to assist in protocol interpretation, enrollment and safety questions.
  • Supervises the daily clinical research operations for the research program, fully integrating research protocols with applicable research management systems and processes.
  • Assists with coordination and implementation of overall research program and associated strategic initiatives.
  • Participates in process improvement activities.
  • Participates in strategic planning and operational implementation.
  • Collaborates with principal investigator, sponsor and research staff to plan, conduct and evaluate project protocols.
  • Analyzes site strengths and weaknesses related to intended protocol and selection of qualified investigators and sites, if applicable.
  • Develops and maintains knowledge of research program and associated protocols to coordinate the comprehensive and compliant execution of protocols.
  • Assists with preparation for and response to audits.
  • Monitors and reports on progress of research projects based upon milestones and contractual payment obligations.
  • Works actively with the principal investigator and sponsor, if applicable, in tracking study progress, developing action plans for not meeting contractual deliverables/timelines, and developing a process to review and follow up with action plans that may include possible discontinuing study and/or site termination, if applicable.
  • Supervises research personnel, ensuring orientation and training, performance management, and career development.
  • Maintains professional relationships, including frequent and open effective communication with internal and external customers.
  • Supervises and assists with the development of training and educational material for assigned research protocols.
  • Provides and documents education as needed.
  • Assists PI with research study design and development of research protocol.
  • Supervises and coordinates research project budget development.
  • Supervises and coordinates research subject recruitment and data management.
  • Assists with the development, implementation and evaluation of research subject recruitment strategies, including marketing strategies, to maximize enrollment and retention.

In-House Clinical Research Associate II

Worldwide Clinical Trials
11.2023 - 03.2024
  • Assisted with feasibility questionnaires and CDA collection from potential sites, as requested.
  • Coordinated study material (e.g., CRFs, manuals) shipment and receipt by study site.
  • Provided applicable updates for site related documentation for filing in the TMF and review collected/received documents for quality in accordance with GDP and WCT SOPs prior to submission to the TMF.
  • Supported field CRA with maintenance of the ISF by assisting with TMF reconciliation and providing support on TMF QCCL.
  • Discussed and assisted field CRA and/or site staff with IP inventory, as applicable and appropriate.
  • Maintained regular communication with sites per the Clinical Monitoring Plan and Site Management and Monitoring Plan, as needed and applicable for assigned study.
  • Assisted sites in resolution of DM issued EDC queries, vendor issued queries, etc.
  • Pulled reports from study-specific portals, EDC systems, etc., created or maintained study-specific trackers, and provided information to CTM for distribution to or use by project team/sponsor.
  • Provided visit preparation support for field CRAs.
  • Assisted with site staff changes as needed or as requested.
  • Assisted with vendor access management for site staff.
  • Supported sites with prescreening, screening, and recruitment.
  • Assisted with Subject Eligibility Review tracking and provided support to Medical Monitor, as applicable and budgeted.
  • Attended and presented updates during study meetings.

Research Coordinator I-III

Cleveland Clinic Taussig Cancer Institute
01.2020 - 11.2023
  • Coordinated the implementation and conduct of research projects ensuring adherence to research protocol requirements, which includes maintenance of regulatory documents and binders, data management, IRB submissions, and communication of such to the research team.
  • Communicated with sponsors, monitors, and research personnel to ensure all aspects of study compliance.
  • Collaborated with primary investigator, sponsor, and research staff to plan, conduct, and evaluate project protocols, including research subject recruitment.
  • Monitored research data to maintain quality.
  • Developed and maintained knowledge of research protocols to coordinate the comprehensive and compliant execution of assigned protocols.
  • Assisted PI with research study design and development of research protocol.
  • Assisted with research project budget development.
  • Managed a portfolio of over 20 medical, surgical, and radiation oncology clinical trials for the Novel Therapeutics and Sarcoma programs.
  • Worked closely with lead sarcoma physicians to determine areas of need for clinical trials.
  • Coordinated Cleveland Clinic’s multidisciplinary sarcoma tumor board.
  • Helped with the creation and implementation of the National Ewing Sarcoma Tumor Board and currently manage its facilitation, working closely with referring and core physicians to schedule cases and collect data on the usefulness of recommendations.
  • Lead weekly Research Coordinator Huddle and biweekly Sarcoma Program Research Group (PRG) meeting.
  • Member of OnCore Teamboard working to create an improved guidance manual for OnCore, which is used to track clinical trial status and accrual and gather data for mandatory NCI reporting.

Patient Service Specialist

Cleveland Clinic Avon Hospital
12.2017 - 01.2020
  • Performed registrations by completing an accurate face-to-face interview to obtain demographic, insurance, medical and financial information.
  • Adapted to relentlessly changing environment and clientele of the Emergency Department.
  • Participated as a member of Kaizen alongside team members using creativity and innovation to solve problems for continuous improvement.
  • Cross-trained to float to Radiology or Outpatient Lab as needed.

Administrative Program Coordinator

Cleveland Clinic
08.2017 - 12.2017
  • Triaged incoming patients from outside of the 8 Ohio counties of Lake, Geauga, Summit, Medina, Lorain, Portage, Cuyahoga and Wayne.
  • Obtained medical records from OSH including EEG reports/scans, radiology reports/scans, neurology progress notes, operative notes, and pathology report.
  • Worked closely with the Director of the Epilepsy Center to schedule patients as quickly and efficiently as possible.
  • Scheduled admissions to the epilepsy monitoring unit that may include additional testing such as ictal SPECT, MRI, PET or MEG scans.

Oncology Patient Care Coordinator

Medical University Of South Carolina
03.2017 - 08.2017
  • First point of contact for new patients and referring physicians.
  • Obtained radiology scans, pathology slides, progress notes, operative notes, chemotherapy flow sheets and discharge summaries from previous institutions.
  • Coordinated medical, surgical and radiation oncology appointments.
  • Assisted the nurse navigator with preparing welcome packets for new cancer patients.
  • Epic super user.

Patient Service Specialist

Cleveland Clinic Richard E. Jacobs Health Center
01.2014 - 03.2017
  • Implemented new scheduling procedures to reduce error and increase patient satisfaction.
  • Served as a member of the patient experience committee dedicated to focusing on patient concerns and creating improvements to increase Press Ganey scores.
  • Functioned as a liaison between patients and departments to expand patient access and schedule patients at their convenience.
  • Provided onboarding training for new employees by designing a desk manual with all of the necessary information for a smooth, successful transition.
  • Applied the Cleveland Clinic values of Quality, Innovation, Teamwork, Service, Integrity and Compassion in my every day work to exceed patient expectations.
  • Served as the point person for department personnel for questions regarding policies and procedures.
  • Assisted in redesigning the referral process for MRI/CT scans.

Education

Master of Public Health -

Cleveland State University
Cleveland, OH
12.2020

Bachelor of Science - Health Care Administration

Kent State University
Kent, OH
12.2011

Skills

  • Research design
  • Project management
  • Regulatory compliance
  • Site management
  • Clinical trial management
  • Data maintenance
  • Protocol development
  • Cross-functional teamwork
  • Strong work ethic
  • Attention to detail

Timeline

Research Supervisor

Cleveland Clinic Taussig Cancer Institute
04.2024 - Current

In-House Clinical Research Associate II

Worldwide Clinical Trials
11.2023 - 03.2024

Research Coordinator I-III

Cleveland Clinic Taussig Cancer Institute
01.2020 - 11.2023

Patient Service Specialist

Cleveland Clinic Avon Hospital
12.2017 - 01.2020

Administrative Program Coordinator

Cleveland Clinic
08.2017 - 12.2017

Oncology Patient Care Coordinator

Medical University Of South Carolina
03.2017 - 08.2017

Patient Service Specialist

Cleveland Clinic Richard E. Jacobs Health Center
01.2014 - 03.2017

Master of Public Health -

Cleveland State University

Bachelor of Science - Health Care Administration

Kent State University

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