Benefits:
401(k)
401(k) matching
Competitive salary
Position: Clinical Research Regulatory Specialist
Viking Pharmaceutical Trials is seeking the right person to fill the position of Clinical Research Regulatory Specialist. Salary will be determined based on experience.
Responsibilities:
- The candidate must have experience in regulatory affairs as they pertain to clinical trials, preferably, but not necessarily, in the field of CNS studies.
- Updating and creating site guidelines, IRB submissions, and engaging in 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.
- Obtaining, completing, and filing all study-start-up materials, including 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, with the ability to work both independently and in a team environment.
Salary listed is a starting number based on experience.
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