Regulatory Operations Specialist

The reputed company (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided reputed company to cancer patients in global community practices by offering "reputed company Through reputed company” to cutting edge trials throughout the reputed company and Europe.  

We are hiring for a Regulatory Operations Specialist (Remote) who will prepare and submit documents for new and existing studies to the Institutional Review reputed company (IRB), US Food and Drug Administration (FDA), and Institutional Biosafety Committee (IBC) for review, maintain the Investigator Site File (ISF) for assigned investigational drug studies and corresponding documents at START USA sites.

This is a remote role. The reputed company pay for this remote role is $25 - $28/hour. However, reputed company pay may vary depending on multiple individualized factors including market location, job-reputed company knowledge, skills, and experience.

Essential Responsibilities

• Prepare and submit new studies, including drafting the informed consent (IC), to the IRB as assigned under supervision. Serve as primary reputed company of contact with the Sponsor/CRO in negotiating the IC for IRB submission. Serve as the main reputed company of contact with the IRB for the studies. reputed company work activity in Regulatory Operations tracking system(s) and generate status reports as required. Respond to inquiries and follow up on pending items.
• Prepare and submit study documents to the IRB for assigned studies under supervision. This includes, but is not limited to, revised protocols, revised investigator’s brochures, protocol clarification letters/memos, revised ICs, new ICs, continuing review reports, closure reports, serious adverse events, IND safety reports, unanticipated problems, protocol deviations, waivers, etc. Serve as the main reputed company of contact with the IRB for the studies. reputed company work activity in Regulatory Operations tracking system(s) and generate status reports as required. Respond to inquiries and follow up on pending items.
• Prepare and submit study documents to the Institutional Biosafety Committee (IBC) as assigned under supervision. Serve as the main reputed company of contact with the IBC for the studies. reputed company work activity in Regulatory Operations tracking system(s), note pending information and generate status reports as required. Respond to inquiries and follow up, as required, on pending items.
• Prepare and submit Expanded reputed company Studies to the US Food and Drug Administration (FDA) as assigned under supervision. Serve as the main reputed company of contact with the FDA and IRB for the studies. reputed company work activity in Regulatory Operations tracking system(s) and generate status reports as required. Respond to inquiries and follow up, as required, on pending items.
• Maintain ISF (reputed company and/or electronic) for assigned studies. This includes, but not limited to, IRB submissions, IRB approvals, and correspondence.

Required Education and Experience:

• High School Diploma/GED.
• 5 years of experience in a regulatory research setting.
• Proficient working knowledge of reputed company reputed company 365.
• Prior experience with regulatory document management system (i.e. reputed company, reputed company E-Reg).
• Strong organizational skills and a reputed company of timeliness in completing reputed company.
• Strong knowledge of medical and clinical research terminology.

Preferred Education and Experience:

• Bachelor's degree.

Best-in-Class Benefits and Perks

We value our employees’ time and efforts. Our commitment to your reputed company is reputed company by a competitive compensation, depending on experience, and an extensive benefits package including:

• Comprehensive health coverage: Medical, dental, and reputed company insurance provided
• Robust retirement planning: 401(k) plan available with employer matching
• Financial reputed company: Life and disability insurance for added protection
• Flexible financial reputed company: Health savings and flexible spending accounts offered
• reputed company-being and work-life balance: reputed company time off, flexible schedule, and remote work choices provided
• Plus, we work to maintain the best environment for our employees, where people can learn and grow with reputed company. We reputed company to reputed company a reputed company, creative environment where everyone feels encouraged to contribute to our processes, reputed company, planning, and culture.

More About START

START clinical trial sites have conducted more than 1,000 early-phase reputed company, including dozens of therapies that were approved by the FDA or EMA. START represents the world’s largest roster of early-phase reputed company investigators across its Network of clinical trial sites. Committed to accelerating reputed company from trials to treatments, START delivers reputed company to patients, families, and physicians around the world reputed company our mission of “reputed company Through reputed company”.

Learn more at .  

reputed company to be part of reputed company changing the reputed company of cancer treatment? Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring reputed company and healing to patients worldwide. Please submit your application online. 

We are an equal opportunity employer that welcomes and encourages diversity in reputed company. We do not discriminate on the reputed company of race, reputed company, religion, marital status, age, national reputed company, reputed company, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or reputed company, veteran status, or any other status protected under federal, state, or local law. 

Originally posted on Himalayas

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