Job Description

Work Location: Sunnyvale, California

Salary Range: $60,000 - $100,000

Job Type: Full-Time Onsite

Our Company:

Founded in 2010, iHealth Labs is dedicated to empowering people to live healthier lives. The company is a leading provider of cloud-connected medical devices, personal health care devices, and home-based tests and is at the forefront of the digital health revolution.

In 2018, iHealth launched its Unified Care program to address the issue of managing chronic diseases. Unified Care specialists support patients at home between doctor's appointments with remote patient monitoring (RPM) and chronic care management (CCM) to achieve better health outcomes.

In November 2021, iHealth's COVID-19 Antigen Rapid Test received Emergency Use Authorization from the U.S. Food and Drug Administration for over-the-counter sales. Since then, iHealth has become a key supplier of at-home COVID tests to the federal government, state governments, nonprofits, and individual consumers.

iHealth Labs is a leader in digital health solutions, with a mission to revolutionize the healthcare industry by making quality health management accessible and affordable for all.

PRIMARY DUTIES AND RESPONSIBILITIES:

• As a (Sr.) Clinical Research Associate, you will be responsible for performing study site management activities. Key responsibilities include conducting on-site or remote monitoring activities.
• Perform site qualification, Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and study close-out visits. Prepare visit reports and other documents associated with these visits.
• Evaluate site facilities and staff to ensure compliance with ICH-GCP guidelines. Assist in and provide feedback on site issues during contract development and negotiation. Participate in investigator meetings and monitor workshops. Oversee and facilitate study start-up activities. Evaluate the quality and integrity of study site practices, ensuring adherence to protocol and applicable regulations. Raise and close monitoring discrepancies.
• Conduct IMVs to confirm that clinical sites comply with study protocols, Institutional Review Board (IRB) requirements, and other regulatory stipulations. Prepare IMV reports and other documentation associated with these visits.
• Maintain and update the TMF with site information, study contacts, and regulatory documents.
• Assist in the termination of clinical studies by identifying items and issues for review or follow-up. Assemble necessary documents, conduct site termination visits (which include test article reconciliation and file review), and retrieve relevant codes and documents. Prepare study termination reports.
• Ensure appropriate transmission of clinical trial data to data management sites. Review case report queries and clarify or obtain changes to data as needed.
• During the close-out visit, the Clinical Research Associate (CRA) must ensure that the clinical trial site has complied with the study protocol, Good Clinical Practice (GCP), and regulatory requirements. The CRA is also responsible for collecting all trial-related documents and archiving them.
• Travel is estimated to be required 25%-50% of the time.

Qualification and Skills:

• Bachelor's degree: Medical/life sciences-related field education
• Minimum 2 years monitoring experience. Experience related to CGM is required.
• Fluent English ability to work independently with minimal supervision.
• Excellent knowledge of GCP guidelines, FDA regulations, and other regulations applicable to the conduct of investigational device 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 provide technical advice, guidance, and support to professional staff in an area of specialty.
• Bilingual in Chinese is required

Benefits:

• Medical, Dental, Vision, Life Insurance, and 401K
• Paid Time Off, Federal Holidays, and Leaves
• Annual Performance-Based Bonus

Job Tags

Holiday work, Full time, Contract work, Interim role, Remote job,

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