Dedicated healthcare professional with a wealth of skills and knowledge focused on improving processes within organizations. Committed to driving innovation and efficiency, I aim to make a positive impact in the workplace. Seeking a challenging role to support organizational missions and make a meaningful difference in the lives of others.
Overview
25
25
years of professional experience
Work History
Volunteer
Dana Farber Cancer Institute
Boston, MA
10.2024 - Current
Provide mini massages for patients during chemotherapy infusions.
Follow pre and post operating procedures while adhering to DFCI policies and training protocols and infection control.
Relate to patients in a positive, caring, and sensitive manner while providing comfort and maintaining healthcare patient privacy standards.
Work with patients and families in stressful situations while remaining empathetic, non-judgmental, and maintaining boundaries. Support all patients and demonstrate sensitivity to cultural, ethnic, and socio-economic differences.
Communicate effectively with all levels of healthcare staff including physicians, nurses and administrators. Work with nurses to review and sign off on patient eligibility.
Maintain proper record keeping in accordance with institutional and HIPAA requirements.
Stay compliant on continuing education trainings and occupational health policies.
Zakim Center for Integrated Therapies and Healthy Living- Hands on Care Program
IRB Member (Alternate)
University of North Carolina - Chapel Hill
Chapel Hill, NC
05.2009 - 01.2023
Review and present research protocols to ensure that human subject research adheres to ethical standards outlined by federal and state regulations, as well as university policies.
Attend IRB meetings and educational, quality improvement, and outreach activities at UNC.
Sr. Clinical Program Lead
Foundation Medicine
Boston, MA
10.2021 - 10.2022
Lead internal FMI study start-up activities including contracting, IRB submission and approval, finalization of study materials including manuals, study specific requisition forms/kits, project specific plans, and sample processing guidelines.
Develop and deliver study start-up training with partner, internal stakeholders, and external clinical trial sites as required.
Work and collaborate closely with Clinical Program Leads, laboratory teams, and Process Specialists to ensure sample tracking and chain of custody is maintained from accessioning through data/report delivery.
Provides comprehensive operational support for FMI's participation in clinical trials sponsored by BioPharma partners, Academic partners, and FMI led trials.
Lead study intake process with partner/collaborator, evaluate feasibility of study with internal stakeholders, and obtain FMI approval to support clinical trials (via CSP, SRC, or PRORECO meeting)
Engage in problem solving as needed related to sample receipt, accessioning, tracking, genomic analysis, report generation, and dissemination.
Customer-centric communication, day to day project management, as well as, operational excellence and oversight of clinical trials
Clinical Operations
Clinical Research Associate
University of North Carolina – Chapel Hill
Chapel Hill, NC
09.2014 - 09.2021
Coordinate and manage pediatric oncology/ bone marrow transplant clinical trials- communication with sponsors and regulatory authorities and interacting with study participants/ study team.
Collect and report time sensitive clinical data accurately and maintain regulatory charts for research patients- adverse event reporting, resolution of data queries, oversee multiple databases and spreadsheets.
Verify and confirm patient eligibility, enrollment and registration for multiple oncology clinical trials- utilizing medical record abstraction and analysis of data.
Collaborate with physicians and nurses for scheduling of clinic and lab visits per protocol requirements.
Ensure all study related tissue samples are collected, processed and shipped according to protocol requirements.
Organizing and preparing for external audits and monitoring visits prepare submission of safety reports and deviations to the IRB- maintaining research protocols with the IRB
Participating in study start- up process for clinical trials- site initiation visits, meetings and trainings
Training new staff and fellows on department research procedures.
Department of Pediatrics- Hematology/ Oncology
IRB Administrator
Copernicus Group
Research Triangle Park, NC
10.2007 - 07.2008
Maintained working relationships with clients by providing IRB services during review and approval process of new research protocols.
Established working relationships between the Institutional Review Board, CROs, and sponsors with research protocol related information to meet deadlines and ensure quality and integrity of work.
Reviewed new study applications and ensured they met internal standards, GCP and federal regulations.
Attended IRB meetings and took minutes on new research protocols.
Created the informed consent documents for Sponsors according to federal regulations and board required revisions.
Fostered client relationships creating sales leads for the Business Development team.
Compliance Officer
Arizona State University
Tempe, AZ
07.2004 - 07.2006
Performed post- approval and continuing review of human subject protocols.
Coordinated all monthly Institutional Review Board meetings.
Consulted with researchers and staff to ensure compliance with federal regulations and universit established practices; involved with the planning of new quality assurance project for office.
Developed new database, procedures, training, and documents to ensure compliance with research activities involving human subjects.
Mediator for complaints in research involving human subjects and coordinated the review of serious adverse events, interviewed subjects that had complaints.
Established and maintained records of monitoring activities.
Office for Research Compliance and Integrity
IRB Coordinator
Harvard Medical School
Boston, MA
05.2002 - 06.2004
Managed communication/ written correspondence with faculty and scientists regarding research, grants, and protocols for compliance of mandatory regulatory requirements.
Coordinated monthly Human Studies Institutional Review Board meetings.
Writing consent forms for principle investigators.
Reviewed initial and continuing approval of designated cooperative agreement protocols involving humans.
Developed and implemented new standard operating procedures and created new office documents.
Administrator of CITI training and NIH certification database for university.
Appointed member of the Harvard University Committee of Research Education.
Department campaign coordinator for the American Cancer Society’s annual Daffodil Days.
Office for Research Subject Protection
Educational Support Specialist
Vality Technology Inc.
Boston, MA
05.2000 - 04.2002
Developed and wrote software education curriculum.
Taught training courses to clients for two software tools.
Managed course registration and client communication. Organized and scheduled education project timelines.
Contributed to construction of access database for company.
Initiated program for the sales of education courses to existing clients.
Education
Bachelor of Science - English Education
Florida State University
Certified Clinical Research Associate - undefined
SOCRA
05.2025
Certified IRB Professional - undefined
PRIM&R
01.2008
Skills
Strong written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology and technical writing
Ability to manage multiple tasks, good prioritization, organizational and problem solving skills
Over 15 years experience in research administration and clinical research management
Working knowledge of Good Clinical Practices guidelines in research
Proficient knowledge with Microsoft Office Suite; REDcap, Medidata RAVE, EPIC EMR