（Sr. ）Clinical Research Associate

Ihealth Labs Inc

2+ years

$60,000 to $100,000 per year

Sunnyvale

10 April 25, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Sr. Clinical Research Associate
Company: iHealth Labs Inc
Location: Sunnyvale, CA, USA
Employment Type: Full-Time
Compensation: $60,000 to $100,000 per year
Benefits Offered: Dental, Life, Medical, Paid Time Off, Retirement, Vision
Work Location: Sunnyvale, California

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 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 in a medical/life sciences-related field.
Minimum 2 years monitoring experience. Experience related to CGM is required.
Fluent in English with the ability to work independently with minimal supervision.
Excellent knowledge of GCP guidelines, FDA regulations, and other regulations applicable to 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

Sr. Clinical Research Associate - slug:

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 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 in a medical/life sciences-related field.
Minimum 2 years monitoring experience. Experience related to CGM is required.
Fluent in English with the ability to work independently with minimal supervision.
Excellent knowledge of GCP guidelines, FDA regulations, and other regulations applicable to 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

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（Sr. ）Clinical Research Associate

Job Description

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