Clinical Research Associate Job at GForce Life Sciences, Sunnyvale, CA

cVJ2QUNWVk5OaElJeTc0b1hLZzBIVGpVckE9PQ==
  • GForce Life Sciences
  • Sunnyvale, CA

Job Description

Sr. Clinical Research Associate

12-month contract

Onsite in Sunnyvale, CA

Responsibilities

  • Support the successful execution of clinical studies by contributing to study design, documentation, and overall management.
  • Lead and manage site start-up and activation processes, including regulatory document preparation, IRB/EC submissions, and clinical trial agreements.
  • Conduct monitoring visits (qualification, initiation, interim, and close-out) and ensure protocol and regulatory compliance through source data verification and study oversight.
  • Serve as the primary liaison for clinical sites, overseeing data entry, investigational device tracking, and issue resolution.
  • Maintain and manage study documentation, including Trial Master File (TMF), clinical trial management systems (CTMS), and site payments.

Qualifications

  • Experience implementing and managing medical device clinical trials.
  • In-depth knowledge of ISO 14155, 21 CFR Part 11, 50, 54, 812, and ICH/GCP regulations.
  • Proficiency in developing study documents (protocols, informed consent forms, CRFs/eCRFs, monitoring plans).
  • Experience with clinical research budgeting and contract negotiation.
  • Proficiency with Microsoft Office Suite, PDF applications, and Electronic Data Capture (EDC) systems.
  • Experience with Clinical Trial Management Systems (CTMS).
  • Prior experience in protocol and clinical section writing for regulatory submissions.
  • Experience in medical device industry is required.
  • Experience with IDE (pre-market) studies.

Job Tags

Contract work, Interim role, Work at office,

Similar Jobs

Fuse Technical Group

Driver Job at Fuse Technical Group

 ...excellent culture for career growth. About the role: The Warehouse Driver Position provides direct receiving and distribution of...  ...By completing this application, you are seeking to join a team of hardworking professionals dedicated to consistently delivering... 

BenCura Rehabilitation Services

Physical Therapist Job at BenCura Rehabilitation Services

 ...rehabilitation provider that partners with healthcare facilities across Georgia and beyond to deliver high-quality physical, occupational, and speech therapy services. Through its commitment to patient-centered care, compliance, and clinical excellence, BenCura supports... 

American Planning Association

Education Associate Job at American Planning Association

 ...Education Associate Full Time Chicago (Loop) Hybrid (Tues/Thrs in office)$50,112 - $57,000 base The American Planning Association (APA), founded in 1978, exists to elevate and unite a diverse planning profession as it helps communities, their leaders, and... 

New York State

Social Work Assistant 2 Job at New York State

 ...that the incumbent of the vacancy will be expected to perform. Duties Description PRIMARY DUTIES AND RESPONSIBILITIES: The Social Work Assistant 2 is responsible for completing assessments in-person and via telehealth video, to include observation, interviews, and documentation... 

AerSale

Training Coordinator Job at AerSale

 ...Essential Duties and Responsibilities: ~ Ensure that the employee training files are maintained in a current and organized manner to...  ...as defined by certifications held by the Company. ~ Coordinate with management throughout the facility to identify shortcomings...