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Actively seeking to hire multiple regulatory coordinators to work remotely to support oncology trials. This is an exciting opportunity with a growing Cancer Institute! Interviews to hire are being set up quickly! No weekends or holidays with benefits offered! Great opportunity if you are looking to work with a well known cancer institute in the US! Can sit anywhere in PA, NJ, or DE
Responsible for preparing and submitting new research protocols, protocol amendments, continuing reviews, investigational product updates (investigational brochures and/or device manuals) and ensuring completeness and accuracy of documents while meeting all applicable submission deadlines.
Responsible for preparing and submitting new informed consent documents, revisions to the informed consent, including any required financial disclosure language, and communicating when IRB requires re-consenting of enrolled subjects. Also ensuring all languages of the informed consent requested by the study team are reviewed and approved.
Ensure all regulatory documents, including all Essential Documents as defined by the ICH/GCP guidelines, are in compliance with all applicable Federal regulations, ICH/GCP guidelines, as well as the Association for the Accreditation of Human Research Protection Programs (AAHRPP) standards and all applicable policies and procedures.
Maintains regulatory documents by creating electronic folders in the eRegulatory application, filing them electronically, following standard file name criteria and keeping all documents current
Ensures the effective dissemination of all regulatory communications and study updates to investigators, study teams, clinical department managers and senior managers, data managers, the IRB, and all other appropriate research staff to facilitate protocol adherence, patient safety, and regulatory compliance.
Ensures regulatory documents for all closed studies are archived and maintained per the applicable regulatory retention period, sponsor requirements, State, IRB, and policies and procedures.
Facilitates proper and timely research credentialing of all research staff and study team members by maintaining the Research Personnel Log ensuring it is accurate and updated in a timely manner. Also maintaining curriculum vitae’s (CVs), licenses and/or certifications, and documentation of completion of all and Sponsor mandatory training.
Confirms with study Sponsor and/or study team if the research protocol is required to be registered on ClinicalTrials.gov, and if required, ensure it is accomplished within the required time period.
Required: Bachelor's Degree or Associate's Degree
1+ years of Regulatory Experience
Experience working within oncology
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