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Clinical Operation Associate information

What is a clinical operation associate?

Clinical Operation Associates are professionals who support the planning, coordination, and execution of clinical trials within pharmaceutical, biotechnology, or clinical research organizations. They help ensure that clinical studies adhere to regulatory guidelines, timelines, and quality standards. Their responsibilities often include documentation management, assisting with trial site communications, tracking study progress, and supporting the clinical operations team with administrative tasks. Clinical Operation Associates play a vital role in the smooth running of clinical trials, contributing to the development of new medical treatments.

What are some common challenges clinical operation associates face when coordinating clinical trials, and how can they be managed?

Clinical Operation Associates often encounter challenges such as managing tight timelines, ensuring regulatory compliance, and coordinating communication among diverse stakeholders. Balancing multiple study sites and adapting to protocol amendments can also add complexity. Effective organization, proactive communication, and a strong understanding of clinical trial processes are key to overcoming these hurdles. Collaborating closely with site staff, clinical monitors, and project managers helps ensure that issues are identified early and addressed promptly, contributing to smoother trial operations.

What are the key skills and qualifications needed to thrive as a clinical operation associate?

To thrive as a Clinical Operation Associate, you need a solid understanding of clinical trial processes, regulatory guidelines, and a relevant degree in life sciences or a health-related field. Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC), and basic project management tools is typically required. Strong organizational skills, attention to detail, and effective communication are standout soft skills in this role. These capabilities ensure regulatory compliance, efficient trial execution, and seamless coordination among stakeholders in clinical research settings.
What are the most commonly searched types of Clinical Operation jobs in California? The most popular types of Clinical Operation jobs in California are:
What are popular job titles related to Clinical Operation Associate jobs in California? For Clinical Operation Associate jobs in California, the most frequently searched job titles are:
What job categories do people searching Clinical Operation Associate jobs in California look for? The top searched job categories for Clinical Operation Associate jobs in California are:
What cities in California are hiring for Clinical Operation Associate jobs? Cities in California with the most Clinical Operation Associate job openings:
Clinical Operation Associate jobs near you
Infographic showing various Clinical Operation Associate job openings in California as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

Associate Director, Clinical Operations Compliance & Training

NexInfo Solutions, Inc.

San Francisco, CA • On-site

Other

Posted 20 days ago

Job description

Job Title: Associate Director, Clinical Operations Compliance & Training

Location: Bay Area, California, United States

A late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company''s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins, along with RAS Companion Inhibitors for use in combination treatment strategies, currently in clinical development.

The Opportunity:

As an Associate Director, you will be responsible for the following:

  • Lead and/or support development and implementation of Google Cloud Platform systems and inspection readiness.
  • Lead and/or support the development and continuous improvement of Clinical Policies/SOPs/WIs/Templates/etc. using knowledge and experience with clinical study management, International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (Google Cloud Platform) and regulatory requirements.
  • SME for Clinical Operations Google Cloud Platform guidance, best industry practices, SOPs, and audit responses.
  • Contribute to the development and management of business and compliance metrics to assess and continuously improve oversight and inspection readiness throughout the clinical trial lifecycle.
  • Support Clinical Operations Inspection Readiness activities with clinical study teams; key participation in Mock/Regulatory Authority inspections.
  • Contribute to the development and execution of Clinical Operations training programs to deliver company standards, Google Cloud Platform, and regulatory requirements.
  • Partner cross-functionally and with QA on quality initiatives, continuous improvement of Google Cloud Platform systems, and internal audits.
  • Line management responsibilities including hiring, performance management, career development, and mentorship.
  • Participate in other Clinical Operations Activities per the business need.

Required Skills, Experience and Education:

  • Bachelor''s degree in biological sciences or health-related field required.
  • 10+ years direct Clinical Compliance, and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industry. Relevant Clinical Operations experience may also meet the requirement.
  • Strong working knowledge of FDA Regulations, ICH Guidelines, and Google Cloud Platform.
  • Demonstrated experience successfully developing and authoring Clinical and cross-functional SOPs ensuring compliance with Google Cloud Platform and regulatory requirements.
  • Experience with development and monitoring of oversight activities.
  • Knowledge and/or familiarity with Ex-US region(s) e.g. EMA, MHRA, PDMA.
  • Ability to perform complex assessments & investigations, draw relevant conclusions, and implement appropriate solutions.
  • Strong analytical, negotiation, and persuasion skills.
  • Ability to deal with time demands, incomplete information, or unexpected events.
  • Outstanding organizational skills with the ability to multi-task and prioritize.
  • Excellent interpersonal, verbal, and written communication skills.
  • Decision-making skills.
  • Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities.
  • Proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
  • Travel may be required (~25%).

Preferred Skills:

  • Line Management experience.
  • Oncology experience, early and/or late stage, strongly preferred.
  • RN or Master''s degree in biological sciences or health-related field preferred.
  • Strong working knowledge of ex-US regulations and requirements.

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