LISSA HEELEY
New York,NY
Summary
Over 20 years of working knowledge in the field of cardiology, with 7 years as a Clinical Research Coordinator for cardiac drugs and device trials and as a Regulatory Coordinator in Radiological Sciences. Therapeutic areas of expertise: Hypertension, and Congestive Heart Failure, Phases II-IV, including 13 years as Administrative Supervisor for a ten – physician cardiology practice. Experience working for Biotech company as a drug safety associate: responsible for drug safety global reporting. Highly organized, detail oriented with an exceptional capacity to multitask: manage competing priorities with ease while maintaining timely study deadlines and regulatory submissions. Proven analytical and problem-solving skills. Outstanding interpersonal and communication skills, both written and verbal. Strong ability to forge positive, productive working relationships with internal and external constituents-physicians, support staff, vendors. Ability to navigate and build strong relationships across all levels of the organization and outside partners, including clinical staff and outside vendors. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
31
31
years of professional experience
Work History
Regulatory Coordinator
UCLA David Geffen School of Medicine
06.2023 - 06.2024
- Assist Principal Investigator, study coordinator and team members in protocol review and study preparation, to ensure that the study is sound from a regulatory and operational point of view
- Act as primary liaison between Principal Investigator, Senior Management, study team sponsor, regulatory agencies/committees, UCLA Investigational Drug Services (IDS) Pharmacy, and appropriate departments (Laboratory, Radiology, Pathology, Cardiology, CTRC, etc.) in discussion of study requirements
- With input from the Principal Investigator and study team, prepare and complete the appropriate regulatory documents for submission to appropriate regulatory agencies/committees in order to obtain study approval
- Prepare and maintain study specific regulatory files (binders) with all appropriate study specific documentation
- Assist with the preparation of study initiation presentation materials for Investigator Initiated studies and Sponsored studies if required, including protocol, IB, study source documents, CRF’s, slides, study handouts, overhead presentations, and lab and procedure manuals
- Assist team with ensuring that all study team members and /or satellite sites have received materials prior to study initiation events (teleconferences and/or meetings)
- Attend study initiation meetings and participate in study initiation and staff training events (teleconferences or meetings) for on-campus clinics, and satellite sites
- Assist study team with training and orientation of treatment staff regarding protocol requirements
- Ensure that all approvals (contract, ISPRC, MRSC and IRB) required for study activation occur
- Notify study team to begin enrollment upon receiving approval from Sponsor and verifying the study is in Care Connect.
Clinical Research Coordinator
National Heart Institute (Formerly Westside Medical Associates of Los Angeles)
08.2022 - 04.2023
- Maintain regulatory documents, subject recruitment, data management
- Collection and processing of biological specimens, and dispensing/administering investigational products
- Coordinate enrollment, conduct study visits, and follow up care of subjects for multiple trials
- Create source documents and establish recruitment plan for new studies
- Responsible for data verification and quality control, ensuring data integrity
- Maintain research related certifications including GCP and IATA
- Liaison between sponsor, regulatory agencies, patient, investigators, office staff.
Concierge Coordinator/Research Support Staff
Pacific Heart Institute/Providence Health and Services
10.2014 - 07.2022
- Support Research Department as necessary in submitting regulatory documents, identifying possible subjects, reviewing possible new drug or device trials for the office, and filling out study documents
- Manage highly profitable concierge program for the practice, representing sixteen physicians
- Over 1200 patients currently enrolled
- Market patient concierge service to both existing and potential new customers
- Continually market upgraded services to existing patients
- Ensure that all patients are greeted and feel valued
- Support patients in whatever questions or concerns they may have, ensure patient satisfaction is of utmost priority
- Assist back office staff with patient intake as necessary-vitals, and EKG’s
- Responsible for major projects
- Lead coordinating and arranging the yearly Women’s Heart Symposium, including obtaining product/service donations from various companies
- Also responsible for other various marketing office practice projects
- Provide office/operational support by facilitating smooth daily operation, by providing direction and supervision in the following areas: administrative assistant coverage, reception and back office to ensure continuous and uninterrupted, efficient work flow
- Assist Practice Administrator as required across functional areas.
Drug Safety Associate
Kaztronix, LLC (Contractor) Genzyme Corporation-A Sanofi Company
03.2011 - 09.2013
- Managed reports concerning drug safety including drug review, case processing, and narrative writing
- Verified information pertaining to case (product, reporter, event, and patient)
- Documented Global Reporting: Submitted Adverse Drug Reaction (ADR) and Suspected Unexpected Serious Adverse Reaction (SUSAR) by providing Medwatch/CIOMS/E2b reports as applicable to US and EU regulatory authorities according to ICH-GCP guidelines, regulatory requirements and company Standard Operation Procedure (SOP)
- Updated safety database with submission date
- Conducted follow-up with reporter i.e
- Clinic, principal investigator, research coordinator, pharmacists, etc
- For duplications and omissions
- Submitted reports to Medwatch/CIOMS/E2b reports
- Updated the safety databases
- Generated follow up letters/queries using the most expedient mechanism and forwarded to clinical sites
- Performed reconciliation with licensing partners and Contract Research Organization (CRO) to ensure compliance and accurate receipt of all adverse event information
- Assisted with imaging of case information to ensure all documents are scanned and archived appropriately in compliance with internal standards and regulatory guidelines
- Adhered to Corrective and Preventative Action (CAPA) from the Quality, Training and Compliance (QTC) group.
Clinical Research Coordinator
Pacific Heart Institute
10.2006 - 06.2010
- Plan and execute Phase II/IV clinical research protocols from SIV to IRB closure; by abstracting, assembling and organizing research data while managing protocol adherence
- Work closely with PI, drug development study operations management, clinical trial sponsor, and internal and external study teams
- Confirm patient eligibility and verify screening procedures are performed within protocol specified windows
- Reporting to local and central IRB’s, Initial Protocol and renewals, SAE’s, Deviations, initial, amendments, annual and close-out visit reports, IRB and sponsor communication and correspondence
- Ensures IRB approved protocols are implemented and followed
- Executes informed consent process and monitors patient status and safety; collects and organizes research data; schedules and conducts study specific training and site in-services to study related staff on new or amended protocols
- Educates patients and their families about study related treatments
- Maintain project scope, budgets, and timelines
- Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required
- Keeping Physicians and site staff up to date on protocols
- Manage Electronic data capture system entry and data query resolution
- Documentation and submission of protocol deviations, adverse events, serious adverse events and endpoints
- Maintaining, completing and submitting regulatory documents
- Study drug receiving, dispensing and accountability of IP
- Collection and processing of labs, ecg’s and any other related patient data as per individual protocol.
Administrative Supervisor
Pacific Heart Institute
11.1993 - 10.2006
- Built and managed office staff by recruiting, selecting, orienting, and training high quality employees
- Managed office staff performance by proactively coaching, counseling, and developing employees; planning, monitoring, and appraising job results
- Facilitate performance evaluation
- Supervised office services by organizing office operations and procedures, preparing payroll
- Managed and developed office processes
- Developed standards by creating job descriptions for different positions in the front office
- Organized and managed physician’s schedule
- Designed training and on-boarding programs
- Managed physician relationships and support
- Ensured that physician’s needs, expectations, and individual requirements are met
- Scheduled patients for diagnostic testing i.e
- Stress echocardiograms, dobutamine stress echo, nuclear, and persantine stress test
- Scheduled patients for outpatient tests i.e., Magnetic Resonance Imaging (MRI), CT scan, angiogram, stent placement, pacemaker implant, defibrillator implant, tilt table test, transesophageal echocardiogram (TEE).
Education
Cum Laude, President’s Honor Roll List - Retail Concepts, Retail Store Operations, Applied Management, Merchandise Trend Analysis, Selling Techniques, International Business
06.2000
Pre-requisite Courses for Nursing: Anatomy, Physiology, Chemistry, Microbiology, Psychology, Math
01.1994
Licensed Vocational Nursing (LVN) -
01.1989
Nurse Assistant -
01.1986
Skills
- Regulatory Submissions
- Global Regulatory Compliance
- Regulatory Policies
- Study Activation
- Subject Recruitment
- Budget
- Dispense Study Drugs
- Study Close Out
- Data Management
Clinicalresearch
- Amgen, OCEAN (a) AMG (890) 2018244, True
- New Amsterdam, PREVAIL TA-8995-304, True
- Applied Therapeutics Inc., ARISE-HF AT-001-2001, True
- Astra Zeneca AB, MIRACLE D6402C00001, True
- AMGEN, VESALIUS 2017625, True
- Rivus Pharmaceuticals, Inc., HUMAIN RIV-HU6-2201, True
- NOVARTIS, CXXB750B12201, True
- Ionis Pharmaceuticals, Inc., IONIS ISIS 678354-CS9, True
- BAYER, FINEARTS-HF 94-8862-20103, True
- Arrowhead Pharmaceuticals, ARO-APOC1, True
- Arrowhead Pharmaceuticals, ARO-APOC2, True
- Arrowhead Pharmaceuticals, ARO-APOC3, True
Training
- Good Clinical Practices (GCP) Clinical Professionals, 03/2027
- UCLA HIPAA, completed 6/2023
- IATA Training, 07/31/2022
- Protecting human research subjects in Biomedical and Genetic Research, 10/27/2006
- National Institute of Health Stroke Scale Administration, 02/19/2010
- Shared Care Research and Education Consulting, Inc. Certification in Standardization of Blood Pressure Measurement, 06/13/2008
- California Medical Compliance training per F.A.A. Regulations to ship blood and body specimens coursework, 10/24/2000
Languages
Tagalog
Native or Bilingual
Timeline
Regulatory Coordinator - UCLA David Geffen School of Medicine
06.2023 - 06.2024
Clinical Research Coordinator - National Heart Institute (Formerly Westside Medical Associates of Los Angeles)
08.2022 - 04.2023
Concierge Coordinator/Research Support Staff - Pacific Heart Institute/Providence Health and Services
10.2014 - 07.2022
Drug Safety Associate - Kaztronix, LLC (Contractor) Genzyme Corporation-A Sanofi Company
03.2011 - 09.2013
Clinical Research Coordinator - Pacific Heart Institute
10.2006 - 06.2010
Administrative Supervisor - Pacific Heart Institute
11.1993 - 10.2006
The Fashion Institute of Design and Merchandising - Cum Laude, President’s Honor Roll List, Retail Concepts, Retail Store Operations, Applied Management, Merchandise Trend Analysis, Selling Techniques, International Business
Santa Monica College - , Pre-requisite Courses for Nursing: Anatomy, Physiology, Chemistry, Microbiology, Psychology, Math
Pacific Coast College - Licensed Vocational Nursing (LVN),
Watterson Skills Center - Nurse Assistant,
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