Clinical Operations Specialist
The Clinical Operations Specialist supports clinical research activities by managing device lifecycles, coordinating trial processes, and maintaining documentation to ensure efficient and compliant clinical trial execution. This role collaborates with cross-functional teams to optimize workflows, track inventory, and support study milestones within an onsite, contract position.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Scientific & QA.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
Position summary
Confidential Client is seeking a Clinical Operations Specialist to support clinical research activities on-site in East Irvine, CA. This is a contract role (12 months, with possible extension or conversion) focused on device lifecycle support, inventory and TMF management, operational coordination, and cross-functional execution of study milestones.
Compensation
- $35–$40 / hour
What You’ll Do
- Support clinical trial operations, device management, and related processes to ensure on-time study execution.
- Coordinate procurement, shipment, receipt confirmation, tracking, and final disposition of study devices.
- Maintain Trial Master File (TMF) documentation and ensure records meet retention and audit requirements.
- Monitor study inventory levels and support forecasting and planning activities.
- Develop timeline assessments with clinical stakeholders to support study milestones and deadlines.
- Generate operational and transparency reporting (including data that supports Sunshine Act compliance).
- Track and coordinate study invoice processing, including review, approval, and payment status reporting.
- Assist with filing, scanning, archiving, and electronic tracking system entry for multiple clinical trials.
- Support clinical research laboratory operations as needed.
- Recommend and implement process improvements to optimize clinical trial workflows.
- Perform other duties as assigned to support clinical study operations.
You’ll Need (Minimum qualifications)
- At least 2 years of clinical research or clinical study operations experience.
- Demonstrated interest in clinical operations and sponsor-side study coordination.
- Ability to work onsite Monday–Friday, 8:00 AM–5:00 PM in East Irvine, CA.
- Strong attention to detail and the ability to manage multiple tasks and timelines.
- Effective written and verbal communication skills for cross-functional coordination.
Nice to Have (Preferred)
- Associate’s or Bachelor’s degree in a related field.
- Direct experience with device management, trial master file (TMF) maintenance, inventory forecasting, or clinical study invoicing.
- Familiarity with regulatory and compliance requirements relevant to clinical trials.
- Experience working with cross-functional partners (Manufacturing, Supply Chain, Finance, Quality, Compliance).
Location & candidate preference
- Onsite in East Irvine, CA (local candidates preferred; applicants in Orange County and nearby Los Angeles County encouraged to apply).
- This is a contract role for 12 months with the possibility of extension or transition to FTE.
Why apply via Careertakes
- Careertakes is a neutral, third-party recruiting platform helping match qualified candidates to Confidential Client roles. Applicants may gain access to additional opportunities through the Careertakes platform and benefit from transparent recruiter support.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind.
To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
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