Clinical Regulatory Assistant
Location: Chapel Hill
Posted on: June 19, 2022
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.
Clinical Research, Regulatory Documents, CRF, IRB submissions,
1572, ICF, Informed Consents
Top Skills Details:
Clinical Research,Regulatory Documents,CRF,IRB submissions,1572,
ICF, Informed Consents
Additional Skills & Qualifications:
*1-2+ years handling and reviewing Regulatory Documents for
Clinical trials *4 year degree Preferred:Oncology Experience
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Keywords: Actalent, Chapel Hill , Clinical Regulatory Assistant, Healthcare , Chapel Hill, North Carolina
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