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IRB/SSU Regulatory Associate-Oncology

Company: N/A

Location: Winston-Salem, NC

Pay: N/A

Contact Information

Name: Louis Muccio
Phone: 9198161621
Fax: n/a
Apply Online

Job Description


This position is for a regulatory associate/start up specialist. The position has the responsibility for IRB submissions for industry, investigator initiated, and cooperative group trials; creating and maintaining professional working relationships with investigators, sponsors, team members, and others. Previous experience in study activation and IRB submissions is required. Previous experience with FDA submissions is preferred.

Day to day duties of this position will include but are not limited to:
*IRB submissions to institutional and central IRBs.
*Providing advice to study team colleagues regarding Federal Regulations, IRB policies, and ICH guidelines.
*Shepherding new studies through the site activation process.
*Meeting with internal and external monitors and sponsor representatives.

Proven ability to provide consultation and lead exchange of research information through technical assistance and instruction. Demonstrated ability to train others, including documenting steps needed to collect information and to independently provide consultation to sites or others related to the specific protocols and regulatory guidance. Demonstrated ability to write comprehensive reports summarizing results and conveying to supervisory personnel. Demonstrated ability to plan work to meet objectives and deadlines.

Significant use of information technology is expected for this position. Experience in clinical research preferred, including familiarity with CFR Parts 50, 54, 56, 312, 314 and ICH Guidelines. CCRP, CCRC, CIRB or RAC Certification preferred.

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.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements