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Regulatory Coordinator
- Insight Global (Los Angeles, CA)
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Job Description
An employer is looking for a Regulatory Coordinator sitting in the Westwood Los Angeles area. This individual will be supporting the regulatory maintenance functions within their HEMOC clinical trials division focused on Lung Cancer trials. They will be supporting 1 PI with up to 35 trials at once; this includes both investigator initiated and industry sponsored trials. This individual will be gathering documents for IRB submissions. This person will help maintain regulatory processes post study activation up until study closeout. This will involve working with industry sponsors to collect protocols, informed consent documentation, updating regulatory documents (1572s and financial disclosures), updating delegation of authority logs, managing monitor visits, and submitting to internal and external IRBs. This person will not be in a patient facing role.
Compensation: $24/hr to $29/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, 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 [email protected] . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .
To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .
Skills and Requirements
-Bachelors Degree
-2+ years of Clinical Research Regulatory experience
-Working knowledge of financial disclosures, 1572s, and inform consent documents
-Experience submitting to an IRB independently
-Experience working with industry sponsor and handling monitor visits
-Experience working within a CTMS system -Experience working with Central AND Internal IRBs.
-CTMS experience with Encore
-Ereg or Ebinder experience such as eflorence
-Experience working on investigator initiated trials (internally funded) 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 [email protected].
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