Administrative Assistant, Regulatory Affairs job at Baylor College of Medicine Children’s Foundation -Uganda

Job Description

JOB DETAILS: Provides regulatory affairs support with administrative maintenance and follow-up. The job holder is responsible for effective documentation and compliance monitoring of research studies. Overall Responsibilities • Administrative Support Services • Review submission packages and facilitate submission to ethical and regulatory bodies. • Develop and maintain tracking system to assess progress on submission. • Develop Standard Operating Procedures that streamline regulatory procedures. • Arrange the timely renewal of practicing license and registration certificates of researchers. • Prepare payments to regulatory authorities in a timely manner. • Research Monitoring Support • Check that all study procedures and reporting are conducted in accordance to the site, protocol, and regulatory guidelines. • Maintain and store all source documents for the study. • Followup teams to confirm that SOP, protocol, and regulatory mandated timelines and IRB reviews are followed. • Participate in internal, regulatory, and compliance monitoring as required. • Communication &Capacity Building Support • Correspond with Ethical and Regulatory bodies. • Provide training for regulatory and protocol related policies to study staff. • Record Keeping • The job holder creates and maintains electronic regulatory binders, logging of safety reports, scanning and uploading regulatory documents as well as processing minor amendments. • Maintain up-to-date regulatory binders. • Ensure proper filing of study documents in properly labelled files while tracking documents coming and leaving the office. • Archiving of completed studies documents. • Reporting • Provide feedback to regulatory affairs coordinator, about all documentation, submissions and communications. Required Qualification, Experience and Competencies: • A Degree in Nursing, Bioethics or related field • Registered with the relevant professional body is key • 2 Years Relevant Experience