Aerotek Regulatory Affairs Specialist in Boston, Massachusetts
Regulatory Affairs Specialist : (100% REMOTE)
NY based Oncology Research Center
Works with the principal investigator to implement, operate, and maintain all regulatory oversight for clinical research activities. Provides professional direction within each research project. Manages protocol development, including meeting regulatory requirements with FDA, IRB, and funding agencies as needed. Works with Study Coordinator to ensure case report form and database development is in place prior to activation of assigned studies. Maintains a working knowledge of the area(s) of expertise by reviewing relevant literature and attending pertinent meetings and seminars. Assists the study team (PI and coordinators) with coordinating center activities, documentation, and databases. Assists Study Coordinators with study document management. Assists investigators with documentation required by granting authorities.
• Prepare all protocol annual reviews, addenda, revisions, memos, safety reports, and consent form revisions for submission to the regulatory committees.
• Submit IRB approval letters and approved consent forms to sponsors as required to ensure studies remain active.
• Supervise the distribution of protocols, addenda, memos to the Hematology/Oncology study coordinators, physicians, support staff, surgeons, pathology, radiation therapy, pharmacy, clinics, units, affiliates, and sponsor offices as needed.
regulatory, IRB, Submission, IND, protocol
Top Skills Details:
Additional Skills & Qualifications:
No degree necessary
IRB Submission experience
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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