Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Personal Information
Professional Areas Of Experience
Timeline
Generic

Lorena Garcia

San Bernardino

Summary

Dedicated and Passionate Clinical Research Coordinator with 20 years of experience in managing complex Phase I, II, III clinical trials, ensuring compliance with protocols. Proven ability to conduct and streamline processes for successful study outcomes for Cooperative and Industry Clinical Trials. Excel at communication, teamwork, and problem-solving to drive successful outcomes in research environments.

Overview

26
26
years of professional experience
1
1
Certification

Work History

Adult Oncology Clinical Research Coordinator I

Loma Linda Medical Center
Loma Linda
01.2006 - Current
  • Coordinate daily activities ensuring protocol specific requirements are achieved in a timely manner.
  • Conduct clinical trials and evaluate the safety and effectiveness of new treatment in human subjects.
  • Conduct data input, retrieval, and analysis, maintaining accurate research databases and ensuring data integrity.
  • Serve as a resource regarding clinical research and compliance for investigators, nurses, and related clinical staff.
  • Manage participant calendar and conducting follow up via phone and in-person, ensuring compliance with study protocol.
  • Work independently as well as promote effective communication among team members.
  • Attend clinic as needed, read, identify, and extract pertinent data from medical records, identify/communicate important protocol and data management issues. Includes reporting SAE, AE’s per protocol.
  • Balances priorities upon receipt of project direction.
  • Prepare/Conduct Internal and External Audits.

Pediatric Oncology Clinical Research Coordinator I

Loma Linda Medical Center
Loma Linda
01.2004 - 01.2006
  • Management of multiple pediatric oncology research protocols to assure efficiency and regulatory compliance of the protocol, Regulatory.
  • Attend Children’s Oncology Group and Investigator’s meetings as required.
  • Implemented stringent data entry protocols, ensuring robust and accurate data collection in clinical trials.
  • Serve as a resource regarding clinical research and compliance for investigators, nurses, and related clinical staff.
  • Work under the direction of the study Investigator with minimal supervision.

Pediatric Oncology - Bone Marrow/Stem Cell Transplant Coordinator

Loma Linda University Health Care
Loma Linda
01.2003 - 01.2004
  • Works under the supervision of the physicians and physician extenders in the Transplantation Institute, and reports to the Transplantation Institute Clinic Supervisor.
  • Manage the entire transplant process for patients, including scheduling appointments, coordinating tests, and facilitating communication between the patient, family, medical team, and referring physicians.
  • Provide comprehensive education to the patient and their families about the process, potential complications, and post-transplant care within the scope of practice for Transplant assistant.
  • Collaborate with the Bone Marrow Transplant team the complex medical regimen involved in the care of Hematology/Oncology and Stem Cell Transplant patients.

Pediatric Oncology - Assistant Case Manager

Loma Linda University Health Care
Loma Linda
01.2001 - 01.2003
  • Provides essential support to Case Manager-Registered Nurse (RN) during patient assessments.
  • Assist in coordinating, organize, and monitor direct nursing care to (infant, toddler, preschooler, school-age, adolescent, young adult, middle adult, later adult.
  • Handling administrative tasks, coordinating services, and ensuring smooth communication between patients and service providers.
  • Providing immediate support during emergencies and assisting in crisis intervention efforts.
  • Streamline workflows, freeing up case managers to focus on more complex aspects of client care.
  • Tracking client progress, reporting updates to the case manager, and ensuring client satisfaction with services.
  • Case manager Assistant works under the supervision of a. Utilizes interpersonal skills to maximize customer excellence in customer service, safe patient care Performs all other duties as needed.

Pediatric Patient Service Representative

Loma Linda University Health Care
Loma Linda
01.2000 - 01.2001
  • Obtains patient demographic, insurance, and guarantor information required to register patients into CHAIS to ensure that complete and accurate accounts are produced.
  • Collaborates with the Insurance Verification Unit, Medical Groups, Health Plans, and Primary Care Physicians to obtain authorization for services and/or treatment.
  • Ensures compliance with all mandated Federal, State and County regulatory requirements and hospital policies.
  • Patient flow for check-in, check-out, and appointments.
  • Managed care, Medi-Cal, Medicare, and California Children’s Services with emphasis on Federal, State, and County eligibility regulations and requirements preferred.
  • Able to communicate in English, relate positively, effectively and professionally with others, provide leadership and supervision.
  • Ability to think critically; work independently with minimal supervision.
  • Work well under pressure; problem solve; organize and prioritize workload; good memory; pay close attention to detail.

Education

Licensed Vocational Nurse -

San Bernardino, CA
01.2001

AS - Associate of Science

SBVC
San Bernardino, CA
01.2000

Skills

  • Data Management
  • Research & Analysis Tools
  • Medidata Rave
  • Clinical Oracle
  • STATA
  • REDCap
  • Clinical CTMS
  • Regulatory & Compliance
  • HIPAA
  • GCP
  • FDA regulations
  • ICH guidelines
  • Interpersonal skills
  • Organizational skills
  • Communication skills
  • Analytical skills
  • Problem-solving skills
  • Presentation skills
  • Coordination skills
  • Ability to prioritize tasks
  • Attention to detail
  • Critical thinking
  • Decision making
  • Knowledge of medical terminology
  • Bilingual in English and Spanish
  • Confidentiality
  • Ethical integrity
  • Clinical trial management
  • Regulatory compliance

Certification

  • SOCRA-Certification Clinical Research Professional (CCRP), 01/01/23
  • NCI GCP: Good Clinical Practice Certification, 01/01/24
  • Human Subjects Protection Training (CITI), 01/01/24
  • Basic Life Support, 01/01/24

Accomplishments

  • Successfully managed clinical trials simultaneously ensuring 100% compliance with regulatory standards.
  • Successfully participated in Adult and Pediatric Oncology Research Audits showing 100% compliance on individual patient cases.

Personal Information

Title: Clinical Research Coordinator 1

Professional Areas Of Experience

  • Adult/Pediatric Oncology/Hematology
  • Adult/Pediatric Bone Marrow/Stem cell Autologous/Allogeneic Transplant

Timeline

Adult Oncology Clinical Research Coordinator I

Loma Linda Medical Center
01.2006 - Current

Pediatric Oncology Clinical Research Coordinator I

Loma Linda Medical Center
01.2004 - 01.2006

Pediatric Oncology - Bone Marrow/Stem Cell Transplant Coordinator

Loma Linda University Health Care
01.2003 - 01.2004

Pediatric Oncology - Assistant Case Manager

Loma Linda University Health Care
01.2001 - 01.2003

Pediatric Patient Service Representative

Loma Linda University Health Care
01.2000 - 01.2001

Licensed Vocational Nurse -

AS - Associate of Science

SBVC

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Lorena Garcia