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Regulatory Coordinator

Company: Aerotek
Location: Sacramento
Posted on: April 10, 2021

Job Description:

Description:The Regulatory coordinator will work with regulatory files and relevant communications must be kept up to date- the coordinator will be responsible for every adverse event that occurs at the other sites. This position will be sitting in front of a computer for most of the day.Skills in the internet are needed- there is an online database for IRB and an internal IRB database as wellCandidates must be able to work with and write consent forms- there is a template they are given, and then insert language into the consent. This candidate will communicate back with pharmaceutical sponsor company if certain things on the consent form can't be changed. Communication will be done via email or phone calls. There is a regulatory staff meeting once per week- attendance is mandatoryObtain city certifications for IRBSite initiation visits- the assigned regulatory coordinator would have to attend this. Submissions are done via IRB-NetThe department started using Industry Reliance- if the sponsor has central IRB, we submit the local IRB to use the central IRB. Local IRB- 2 committee meetings per month, looking to get things on timeEach coordinator has their set of oncology trials- but they cover for each other- use the group email a lot for Regulatory. Typically this person would be working with approximately 15-20 trials. Prepping documents for submission to IRB as well as submitting directly to the IRB.Must be comfortable with local institution IRB as well as other IRB's- central IRB's- Quarum. The clinical trial management syste is Velos- clinical folks will upload information, regulatory folks will control the versions and who has access to what.Skills:regulatory coordinator, IRB submission, Local IRB submissionAdditional Skills & Qualifications:H.S. Diploma or B.S/B.A.Minimum 1 year of experience in Regulatory- Academic or research setting is a must and Oncology or infectious disease experience is preferred but not required. Must have site experience; they are doing regulatory submissions to the local IRB. Someone who has dealt with IB's (Investigator Brochures) Someone with experience in IRB policies and procedures, IRB submissions, with the ability to write consents. The candidate must need to have good working knowledge of excel. Oncology experience highly preferable, infectious disease is okay as well but they are open.Communication is very important- communicate with clinical staff if there is a an issue that comes up. Someone with great attention to detail/project management. Working at a CRO or Pharmaceutical is completely different than in an academic setting. They are processing materials a site is sending them.Candidates who are doing some regulatory submission to the IRB will be okay- if they want to focus in Regulatory. Local IRB experience is required; if a candidate has only central IRB they would need too much training. Candidates must have excellent written and verbal communication skills About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Sacramento , Regulatory Coordinator, Other , Sacramento, California

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