Actalent Clinical Regulatory Associate in Chapel Hill, North Carolina
The Regulatory Associate is responsible for regulatory compliance clinical trials performed by the assigned disease group. The position requires that the person be responsible for IRB submissions and responses and for creating and maintaining professional working relationships with investigators, sponsors, team members, and others. • Obtain written and dated approval from the IRB for trial protocols, written informed consent forms and updates, subject recruitment procedures (advertisements) and any other written information to be provided to subjects. • During the course of the trial, provide all documents to the IRB that are subject to review. • Submit protocol deviations for IRB review according to IRB and SOPs. • Submit written summaries of the trial status to the IRB annually, or more frequently if requested by the IRB. • Promptly provide written reports to the IRB on any changes significantly affecting the conduct of the trial and/or increasing the risk to subjects. • Report unexpected serious adverse drug reactions to the IRB according to IRB SOPs. • Revise written informed consent form and any other written information to be provided to subjects whenever important new information becomes available that may be relevant to the subject’s consent. Obtain IRB approval prior to distributing for use with subjects. • Prepare for monitoring and audit by the sponsor and inspection by appropriate regulatory authorities. Meet with sponsor representatives and inspectors. Provide information at time of visit and follow up on actions identified in monitor and audit reports within 30 days. • Support trial-related knowledge in assigned disease group by participating in start up meetings and by organizing and documenting training on amendments. • Support Pod Meetings by providing documenting information on new study selection and activation, trial and accrual status, and implementation of regulatory functions.
Clinical Research, Regulatory Documents, CRF, IRB submissions, 1572, ICF, Informed Consents, Irb, Regulatory affairs, Regulatory submission, Oncology
Top Skills Details:
Clinical Research,Regulatory Documents,CRF,IRB submissions,1572, ICF, Informed Consents,Irb,Regulatory affairs,Regulatory submission
Additional Skills & Qualifications:
*1+ years handling, reviewing, and submitting Regulatory Documents for Clinical trials (site level) *4 year degree Preferred: Oncology Experience
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