Job Description

Insight Global is looking for a Level II OR Sr. Regulatory Affairs Coordinator to join one of the largest oncology networks in the US. The candidate will open, track, and close studies being done within the cancer centers to understand the efficacy of drugs used to treat patients. This is a highly regulated environment, and the individual will need to be computer savvy, and have familiarity with regulatory terms, documents, and processes through phases 1,2, and 3 of the study. They will sit onsite for all 5 days during training (3-months) and then have the ability to be hybrid with only 1 day onsite. The client is looking to bring someone on long-term. There will be growth opportunities within the organization relatively quickly if the candidate has enough experience.

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

• 3+ Years experience with regulatory documents/studies within healthcare (feasibilities, Scheduling, SIV's - (SIV = Sight Initiation Visit to start a study)

• Able to handle 25+ studies at a time

• Able to open, maintain, and close a study with little supervision

• Familiar with the 3 phases of study (phase 1 = dosing, phase 2 = efficacy, phase 3 = comparison to standard treatment options within the industry) 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.