Clinical Study Associate

Job Description

A large medical device company located in Irvine, CA is looking for a Clinical Study Associate to support the planning, executing, and management of clinical trials. The responsibilities will include but are not limited to:

Assist in the preparation and review of study-related documents, including protocols, consent forms, and reports

Coordinate and manage logistics for clinical trials

Ensure accurate and timely data collection, entry, and reporting.

Monitor study progress and maintain study timelines.

Communicate effectively with study sites and internal teams to resolve issues and ensure smooth study conduct.

Assist in the preparation of regulatory submissions and responses to regulatory agencies.

Maintain study files and documentation in accordance with Good Clinical Practice (GCP) and company SOPs.

Participate in team meetings and provide updates on study status

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Skills and Requirements

Bachelors degree in life sciences, nursing, or a related field.

1 year of experience in clinical research or a related field.

Knowledge of GCP, ICH guidelines, and regulatory requirements.

Strong organizational and time management skills.

Excellent communication and interpersonal skills.

Proficiency in Microsoft Office Suite null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.