Benefits:
401(k)
401(k) matching
Competitive salary
Viking Pharmaceutical Trials is seeking the right person to fill the position as a Clinical Research Regulatory Specialist. Salary will be determined based on experience.
· The candidate must have experience in regulatory affairs as they pertain to clinical trials, preferably, but not necessarily, in the field of CNS studies.
· Duties will also be the updating and creation of site guidelines, IRB submissions, and frequent discussions with our principal investigator regarding protocol version updates, overseeing necessary site training, including GCP and other annual and bi-annual training, and preparing the site for all monitoring and audit visits.
· Duties will be all-encompassing and include obtaining, completing, and filing all study-start-up materials. Also, the creation of a complete ISF Binder before the site initiation visit
· Systematic, organized, and regular upkeep of all documents required throughout the lifespan of our contracted clinical trials; from the SIV through the close out visit.
· Strong verbal and written communication is mandatory, ability to work both independently and in a team environment.
Salary listed is a starting number based one experience.
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