Jessica Lynch, CCRP
Yorba Linda,CA
Summary
Experienced in utilizing Microsoft Office Suite, including Word, PowerPoint, Excel, and Outlook. Skilled in navigating Electronic Medical Records (EMR) and Electronic Data Capture (EDC) systems. Holds certifications in SOCRA's CCRP, Good Clinical Practice (GCP), and Protecting Human Research Participants. Exhibits exceptional project management abilities, meticulous attention to detail, analytical thinking, organizational proficiency, effective problem-solving skills, and a self-driven mindset.
Overview
26
26
years of professional experience
Work History
Associate Clinical Research Specialist
SI-BONE
05.2023 - Current
- Closely work with a team to support multiple clinical studies
- Responsible for study document creation, trial master file maintenance, clinical site support
- Site training as needed
- Acts as a resource to clinical research staff to ensure standards for data management and quality assurance are adhered to in each study
- Monthly clinical payment calculation
- Oversees and coordinates daily operations of the clinical research team
- Clinical site support for materials request
- Performs GCP tracking and compliance for multiple clinical studies, including payments, and sensitive healthcare information
- Data management, Clinical inventory management, and proactive in all duties
- Prepares and maintains clinical documents, provides support in reviewing and assessing study protocols, case report forms, informed consent, and recruitment materials
- Follows GCP to ensure all studies and sites are in compliance with study protocols
- Ensures compliance with SOPs and research protocols by providing ongoing quality control audits of study TMFs
- Orders and maintains inventory of clinical supplies
- Assembles and prepares distribution of study supplies
- Tracks and prepares reports of clinical milestone payments for accounting
- Maintains & updates clinical databases (e.g EDC system, clinicaltrials.gov, MS Teams, etc.) IRB submissions and continuing review
Practice Manager and Clinical Research Coordinator
Centers of Rehabilitation and Pain Management / Western Clinical Research
02.2020 - 05.2023
- Responsibilities include Study start up, contracting and budget development and negotiations
- Protocol review, ensuring that all costs are covered in the budget including but not limited to study start up fees, Sponsor visits, patient visits, procedure coding and billing, IRB fees, PIs time, set up and close out
- IRB Submissions/correspondence, maintaining regulatory documents, screening of potential subjects, obtaining informed consent, maintaining accurate patient data and device accountability, vitals and EKG
- Responsible for the accurate recording of research patient data and study-related information into case report forms (CRFs) into the electronic data capture systems (EDC)
- Liaison between the Sponsor, IRB, CRAs and Principle Investigator
- Understanding of medical procedures, medical terminology and diagnostics
Spine Surgical & Research Coordinator
Executive Medical and Surgical
01.2008 - 06.2019
- Certified with SOCRAs CCPR, 'Good Clinical Practice' and 'Protecting Human Research Participants'
- WIRB submissions, screening potential subjects, obtaining informed consents prior to any treatment related to the trial
- Obtaining and scheduling all forms of diagnostic testing needed
- Making sure all inclusion and exclusion criteria is met
- Maintaining proper patient enrollment, CRF paperwork, signatures, surgery scheduling, randomizations, and scheduled follow up visits
- Present in the OR for all trial patients surgeries
- Properly labeling and sending pre and postoperative imaging to the lab
- Scheduling monitor visits with prepared and maintained patient binders, clinical charts and regulatory binders
- Responsible for trial devices
- Ensuring each patient follows the trial protocol from start to finish
- Responsible for doctors credentialing
Spine Surgery Scheduler/Clinical Coordinator
Carl Lauryssen, MD at Tower Orthopaedics
01.2005 - 01.2008
- Experience with FDA Clinical Trials
- Maintain surgery schedules and coordinate surgical functions between hospital, surgeon(s) and patient
- Following up on prescriptions for medications, MRI’s, CT’s, injection and all other diagnostic studies ordered by doctor
- Obtaining pre authorization for surgery – communicate diagnosis and procedure codes to insurance companies
- Providing cost estimates to patients according to the surgeons fees and patients insurance benefits
- Ensure proper surgical equipment, DME and supplies, films, records, consult reports, diagnostic studies and pre-op labs are at hand
- Manage patient visits from entry to exit
- Knowledge in post-op care – dressing changes, suture, staple and pain pump removal and injections
- Proofing both operative reports and consultation reports for billing
- Schedule and organize surgeons’ depositions - prepare charts, films, etc
- Manage surgeons’ correspondence – mail, fax, voice and email
- Liaison between Workers Comp Insurance company and the surgeon
- Maintaining Doctors Outlook Calendar and personally communicating with him for critical appointments
- Participate in marketing surgeon and hospital facilities through brochures, marketing paraphernalia, and various media
- Filling out privilege packets and insurance contracts
Office Manager
Totty Printing
01.1999 - 01.2005
- Company Overview: Wholesale printing manufacturing and Bindery Company
- Manage all files and incoming work from receipt through preparation, typesetting, proofreading, printing and bindery (if required)
- As time is of the essence in the printing business I insured a turnaround time that averaged 2-3 days in an industry that averages 7-10 days
- Process quotes, work orders and purchase orders and order all necessary supplies, ink, paper, plates, etc
- To guarantee that all jobs are completed accurately and in a timely manner
- Responsible for all administrative duties, Accounts Payable and Receivable, collections, financial and AP/AR reports, scheduling appointments, accurate alpha and numeric filing
- Wholesale printing manufacturing and Bindery Company
Education
Associates Degree - Product Development
FIDM
Los Angeles, CA01.2003
AA - Liberal Arts
Rancho Santiago College
Orange, Ca01.2001
High school or equivalent -
El Dorado High School
Yorba Linda, CA01.1999
Skills
- Site and remote monitoring
- Patient recruitment
- Good clinical practice
- Reliability
- Effective communication
- Accurate data collection
- Quality assurance
- Multitasking
- Time management
- Problem-solving aptitude
Summaryofqualifications
Microsoft Office: Word, Microsoft Office: PowerPoint, Microsoft Office: Excel, Microsoft Office: Outlook, Electronic Medical Records (EMR), Electronic Data Capture (EDC) systems, SOCRAs CCRP, Good Clinical Practice (GCP), Protecting Human Research Participants, strong project management, detail oriented, analytical, organization, problem solving, self driven
Timeline
Associate Clinical Research Specialist
SI-BONE
05.2023 - Current
Practice Manager and Clinical Research Coordinator
Centers of Rehabilitation and Pain Management / Western Clinical Research
02.2020 - 05.2023
Spine Surgical & Research Coordinator
Executive Medical and Surgical
01.2008 - 06.2019
Spine Surgery Scheduler/Clinical Coordinator
Carl Lauryssen, MD at Tower Orthopaedics
01.2005 - 01.2008
Office Manager
Totty Printing
01.1999 - 01.2005
Associates Degree - Product Development
FIDM
AA - Liberal Arts
Rancho Santiago College
High school or equivalent -
El Dorado High School
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