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Aerotek Senior Regulatory Coordinator in Evanston, Illinois

Description:

Specific Responsibilities:

• Determines and interprets applicable rules and regulations associated with clinical research studies and trials involving human subjects ensuring the protection of their safety, rights, and welfare. Guides and coordinates all associated submission, documentation, and reporting processes (new study applications, renewals, revisions, modifications, amendments, adverse events, safety reports, close-out, etc.)

• Acts as liaison between research staff (PI, faculty, nurses, technicians, etc.), and internal/external regulatory and oversight groups (IRB, sponsors NIH), government agencies (FDA, etc.) to resolve issues and problems, negotiate compromises, and offer alternatives and recommendations to facilitate and expedite research while ensuring compliance.

• Determines compliance required documentation and develops necessary items such as protocols, informed consent, etc. Ensures accuracy of IRB approval letters with respect to sponsor information and NIH grant identifiers.

• Provides guidance and training to junior staff and research staff to ensure compliance with complex, highly specialized rules and regulations associated with clinical research studies and trials involving human subjects.

• Researches new and updated rules and regulations associated with clinical research studies and trials involving human subjects. Alerts appropriate staff to changes and ensures appropriate interpretation and application to new and existing studies and trials.

• Maintains the regulatory portion of the CRO database. This includes IRB approval dates, revision dates, protocol status, and adverse event tracking

Skills:

Regulatory, Irb, Clinical research, Oncology, Gcp, Regulatory documents, FDA, CRF Regulatory affairs, Clinical trial, Regulatory submission, Ctms, etc.

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.

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