Clinical Research Coordinator

Professional Summary

Clinical Research Coordinator with over 7 years of experience in managing comprehensive clinical research protocols, especially in oncology. Proficient in IRB guideline adherence, patient consent processes, and data management through EDC systems. Skilled in coordinating site visits and training research staff, ensuring meticulous compliance and operational excellence in fast-paced environments.

Employment History

04/2024 – Present

Lead Clinical Research Coordinator, Folio Clinical Research (SMO) at Valley Urology Inc., Fresno, CA

•SMO Start-up Urology Specialty Clinic

•Set-up site research office, manage multi-site industry sponsor clinical trials Phase II through Phase IV in urology clinical trials.

•Consent patients, follow the visit schedule and submit proper data to designated electronic data capture systems.

•Responsible for protocol specific time points, specimen collection, preparing laboratory samples for shipping to specified central laboratory and management of central lab kit inventory.

•Performing vital signs, ECGs according to protocol requirements, scheduling patient follow-up visits.

•Submissions of pre-site visit feasibility questionnaires and study start up documents.

•Coordinate pre-site visits, site initiation visits, remote/onsite visits, and close out site visits.

•Serve as first point of contact for remote/on-site study monitoring.

04/2021 – 02/2024

Clinical Research Coordinator, COGI-WCRN, Inc. formally WCRN/COGI, Fresno, CA

•SMO Women’s Oncology focuses on Breast and Gynecological Cancer.

•Knowledgeable of inform consent form process, following visit schedules, submitting proper data to EDC systems and vendors.

•Responsible for preparing study laboratory for shipping according to protocol requirement, performing vital signs and ECGs according to protocol requirements, schedule follow up visit appointments, creating daily clinic orders for new and existing research patient, screening activities needed per protocol, manage protocol specific central lab kit inventory.

•Assist management with development/implement department SOPs.

• Submissions of pre-site visit feasibility questionnaires and study start up documents. Coordinate pre-site visits, site initiation visit, remote/on-site monitoring visits and close out visits.

•Conduct, manage, and maintenance of protocol specific training for all research staff. Manage delegation of authority logs up to date.

12/2022 – 06/2023

Digital Health Specialist, N-Power Medicine, Inc., Redwood City, CA

•SMO located in Monterey, Ca at Pacific Cancer Care

•Onsite study coordinator consenting patients to a registry study

•Documenting and uploading patient consents to OncoEMR and corresponding EDC system.

•Daily huddle with treating physicians regarding the patient load

•Management of onsite ISF binder

10/20217 – 10/2021

Clinical Research Assistant and Regulatory Associate, California Cancer Associates for Research and Excellence (cCARE), Fresno, CA

•High volume oncology facility participating in Phase I through Phase IV multi-site industry clinical trials.

•Management of all study related regulatory documentation in Investigator Site File

•Submitting appropriate regulatory documentation to central and local IRB for Initial, continuing, and final review. Extensive knowledge of IRB guidelines.

•Submission of pre-site visit feasibility questionnaires and study start up documents.

•Coordinate pre-site visits, site initiation visits, remote/on-site monitoring visits, and close out visits.

•Ample experience in inform consent form process, adherence to visit schedule, submitting proper data to EDC systems and vendors.

•Contributed to project management with development/implementation of department SOP’s.

•Conduct, manage, and maintenance of protocol specific training for all research staff. Manage delegation of authority logs up to date.

•Served as first point of contact for study monitors when scheduling site or remote visits. Manage study monitor’s user access to site’s EMR system.

•Clinical Research Assistant: responsible for processing lab specimens, shipping according to protocol requirements, performing vital signs and ECGs per protocol requirements.

•Assisting the Clinical Research Coordinator with scheduling follow-up patient visits.

•Assist CRC with screening activities

•Inventory control of central lab kits.

11/2015 – 10/2017

Medical Assistant Back Office, Community Medical Centers Ambulatory Care Center Family Practice, Fresno, CA

•Taking patient intake, assessing patient vital signs in a fast-paced office.

•Performing EKGs

•Daily patient huddles with resident doctors

•Sanitizing exam rooms, restocking, and distributing test samples to local lab

•Assist with procedures, endometrial biopsy, colposcopies, and pap smears. Set-up of intra uterine device insertion and removal. Administer injections and vaccine immunizations

•Responsible for maintaining and delivery of CHDP billing forms to designated department.

Skills

Management of onsite ISF binder

Vast knowledge of IRB guidelines

Screening activities per protocol

Quality Assurance

Clinical Trial Management

Current GCP and IATA certificates

Accolades

Employee of the year issued December 2019 at cCARE

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