监管运营专员

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering "Hope Through Access” to cutting edge trials throughout the United States 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 Board (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 hourly pay for this remote role is $25 - $28/hour. However, base pay may vary depending on multiple individualized factors including market location, job-related 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 point of contact with the Sponsor/CRO in negotiating the IC for IRB submission. Serve as the main point of contact with the IRB for the studies. Enter 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 point of contact with the IRB for the studies. Enter 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 point of contact with the IBC for the studies. Enter 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 Access Studies to the US Food and Drug Administration (FDA) as assigned under supervision. Serve as the main point of contact with the FDA and IRB for the studies. Enter 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 (paper 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 Microsoft Outlook 365.

• Prior experience with regulatory document management system (i.e. Veeva, Advarra E-Reg).

• Strong organizational skills and a sense of timeliness in completing projects.

• 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 success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including:

• Comprehensive health coverage: Medical, dental, and vision insurance provided

• Robust retirement planning: 401(k) plan available with employer matching

• Financial security: Life and disability insurance for added protection

• Flexible financial options: Health savings and flexible spending accounts offered

• Well-being and work-life balance: Paid 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 the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.

More About START
START clinical trial sites have conducted more than 1,000 early-phase clinical trials, including dozens of therapies that were approved by the FDA or EMA. START represents the world’s largest roster of early-phase principal investigators across its Network of clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world via our mission of “Hope Through Access”.
Learn more at .  
Ready to be part of a team changing the future 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 hope and healing to patients worldwide. Please submit your application online. 
We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. 
Originally posted on Himalayas