Clinical Research Associate (In-House)

Location

Irvine, CA

Status

Full Time

Job Summary

CathWorks, based in Israel and Irvine, CA, is a fast-paced medical device start-up focused on digital health innovations to improve the lives of patients globally. The CathWorks FFRangio® System combines artificial intelligence (AI) and computational science to provide physicians with comprehensive physiologic information, enabling them to make better treatment decisions for their patients with coronary artery disease.

Recently, CathWorks entered into a strategic partnership with Medtronic to market and sell the FFRangio System globally. Medtronic is the global leader in medical technology and has more than 90,000 employees worldwide in more than 150 countries. The partnership with Medtronic will expand CathWorks’ footprint globally, enabling more patients to benefit from its revolutionary technology that is poised to disrupt the current coronary physiology market.

As the Clinical Research Associate (Clinical Research Associate) at CathWorks, you will play a crucial role in planning and executing company sponsored global clinical trials for the CathWorks FFRangio® System. It is a hands-on, high impact role with the opportunity to help transform how physicians manage patients with cardiovascular disease. If you have the entrepreneurial drive, demonstrated ability to collaborate with a variety of stakeholders in a fast-paced, “start- up” environment, CathWorks is the place for you.

Job Responsibilities

Support clinical study start-up activities
Assist in preparation of IRB/EC submissions including quality review of site-specific informed consent and complete the ICF consent checklist
Arrange for certified translations of study documents, when necessary
Lead and support set-up and maintenance of TMF
Ensures timely collection of study documentation by obtaining, maintaining all necessary records and documentation according to procedures and regulations.
Interface with field CRAs/CROs to address and resolve queries.
Contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, data entry timeliness, data query follow-up, NDA finding follow-up and action item resolution or other sponsor specific tasks)
Support and liaise with field CRAs to obtain/share trial specific documents and assist in site issues
Work closely with Clinical Study Manager to ensure clinical studies are conducted in accordance with protocol, GCP, SOPs and all applicable regulations (e.g., FDA)
Assists in verifying investigator qualifications, training and debarment check
Assists with the tracking and management of EDC during study (e.g., site payments, query resolution, etc.)
This is an in-house CRA role reporting to Clinical Study Manager and does not have direct site monitoring responsibilities.

Job Requirements

BA/BS degree with at least two (2) years clinical trial experience and site management
Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
Must have demonstrate core understanding of medical terminology and clinical trial activities/management.
Must have excellent interpersonal, written, and verbal communication skills, administrative skills and computer ability (MS Office, MS PowerPoint).
Fluent in English.

About CathWorks

CathWorks is the leader in digital health innovations that can improve the lives of patients globally. The CathWorks FFRangio® System combines AI and computational science to obtain physiologic information from routine angiograms (X-rays), eliminating the need for drug stimulation and invasive pressure wires. It provides physicians with a quick and reliable intraprocedural physiologic assessment for the entire coronary tree, making it practical for every patient. For more information on CathWorks, visit www.cath.works and follow @CathWorks on Twitter and LinkedIn.

Equal Opportunity Employer

CathWorks, Inc. is an Equal Opportunity Employer. This company does not and will not discriminate in employment and personnel practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by applicable law. Hiring, transferring and promotion practices are performed without regard to the above listed items.

Unless stated otherwise, all positions posted for CathWorks are not intended for or open to third party recruiters/agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.