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Clinical Research Regulatory Protocol Specialist

Company: Aural Analytics, Inc
Location: Scottsdale
Posted on: November 19, 2020

Job Description:

At Aural Analytics , we're developing the world's most advanced suite of clinical-grade speech analytics for health applications, across the lifespan.

We're looking for a candidate experienced in clinical trial protocol development and regulatory submissions to help lead the development of our growing portfolio of Aural Analytics sponsored studies. A successful candidate will have experience working on clinical trials specifically working with clinical teams in writing and developing protocols, and ICFs, preferably in digital health and/or neurology, and have experience in clinical trial regulatory work, including IRB and FDA submissions as a leading author (preferable SaMD or an MD that relies on software).

This role will:

Assist in the design and drafting functions of study protocols for the ever-growing portfolio of Aural Analytics sponsored studies.

Assist with regulatory activities including design and drafting of all submissions and documentation for internal and external submissions (i.e. FDA)

Work with internal and external resources to help ensure proper compliance with applicable regulations and best practices.

Liaison between IRB, investigators, program managers, study team, and industry sponsors.

Ensure new protocols are submitted to IRBs or other bodies within established time frames by compiling and coordinating appropriate paperwork.

Review incoming protocol amendments and revisions from sponsors, identifying necessary steps for processing, and consult with key stakeholders.

Maintain and update study regulatory/legal documents per guidelines and company objectives.

Requirements:

5+ years of Clinical research and protocol experience - Required

3+ Years of FDA, IRB administration, research, and/or regulatory affairs - Required .

Proficient in advanced computer skills; proactive strong organizational skills. Excellent verbal and written interpersonal skills.

Preferred Qualifications:

Preferred: Professional certification in research; CCRP, CCRC, CIP, or RAC.

We are offering this role as full-time or part-time employment

Keywords: Aural Analytics, Inc, Scottsdale , Clinical Research Regulatory Protocol Specialist, Other , Scottsdale, Arizona

Click here to apply!

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