Clinical Research Associate

iHealth is dedicated to empowering healthier lives. As a pioneer of digital health from Silicon Valley, iHealth was founded in 2010 and launched the world's first Bluetooth-connected blood pressure monitor that worked with iOS devices. Through more than a decade of development, by integrating its FDA-approved, award-winning consumer medical devices and remote patient monitoring platform, iHealth has established a digital health ecosystem, the Unified Care model, for healthcare providers to manage chronic diseases remotely. To date, iHealth is one of the top brands in digital health & wellness and has expanded its Unified Care model to 13 states with significant clinical outcomes in hypertension and diabetes management.

During the first year of COVID-19 pandemic, iHealth was actively supporting the fight against COVID-19 by being one of the leading manufacturers of thermometers, shipping millions of them to its customers.

On November 5th, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for over the counter (OTC) sale of iHealth's COVID-19 Antigen Rapid Test. iHealth has since been a major supplier of at-home tests to the federal government, state governments, nonprofit organizations, and individuals.

Work Location: Onsite in San Jose, CA

PRIMARY DUTIES AND RESPONSIBILITIES: 

• As a Clinical Research Associate you will be responsible for performing wing to wing study site management activities.The Clinical Research Associate's Key responsibilities will consist of: on-site visits and monitoring activities (phase II, III and IV)

• Contributes to the site and investigator selection process providing site-level information for the country recruitment plan

• Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in the establishment of baseline parameters and edit check specifications, and in the development of subject tracking systems.

• Evaluates site facilities and staff to ensure that it meets ICH-GCP guidelines assisting and providing feedback on sites issues during site contract development and negotiation process participating on the investigator meeting and monitors workshop overseeing and facilitating Start-Up activities evaluating the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations raising and closing monitor discrepancies Požadujeme 

• Oversees the development of clinical trial protocols; participates in the development of the overall clinical plan, drafts protocols, collaborates on statistical analysis plans, and coordinates the protocol review and approval process, to include submissions to regulatory agencies.

• Perform site qualification, SIV, IMV and study close-out visit. Prepare visit reports and other related documents in association with visits. 

• Maintain and update the CTMS with site information, study contacts, regulatory documents.

• Perform IMV to confirm the clinical sites compliance with study protocol, IRB and regulatory requirements. Prepares IMV reports and other related documentation in association with visits.

• Assists in the termination of clinical studies by identifying items and issues for review and/or follow-up; assembles necessary documents, conducts site termination visits to include test article reconciliation and disposition, review of completeness and accuracy of files, and retrieval of relevant codes and documents; prepares study termination reports.

• Ensures appropriate transmission of clinical case data to the data management centers; reviews case report queries and problems, and clarifies and/or obtains changes to data as appropriate.

• Estimated travel was required 15%-35%.

Qualification and Skills: 

• Bachelor's degree: Medical / life sciences related field education minimum 2 years monitoring experience.

• Fluent English ability to work independently with minimal supervision.

• Excellent knowledge of GCP guidelines, FDA regulation and other regulations applicable to the conduct of investigational devices studies.

• Good written and verbal communication skills.

• Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment.

• Ability to establish data collection and management guidelines.

• Ability to provide technical advice, guidance, and support to professional staff in an area of specialty.

Pay Range : $65K - $85K