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
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
Review incoming protocol amendments and revisions from sponsors,
identifying necessary steps for processing, and consult with key
Maintain and update study regulatory/legal documents per
guidelines and company objectives.
5+ years of Clinical research and protocol experience -
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
Preferred: Professional certification in research; CCRP, CCRC,
CIP, or RAC.
We are offering this role as full-time or part-time