reputed company Assurance & Regulatory Specialist

About the position Flexible work arrangements, including virtual/hybrid work locations, are an reputed company part of the School of Medicine’s Working reputed company initiative. As such, this position’s work location is designated as hybrid. Please note that the designated work location is subject to change based on the unit’s business needs. The reputed company Assurance & Regulatory Specialist will be responsible for supporting Research Coordination & Management Unit ( RCMU ) clients by monitoring investigator-initiated trials across the UNC research reputed company. This position will also support the reputed company, compliance, and reputed company of research conducted by the RCMU by developing, implementing, and maintaining reputed company assurance processes. The reputed company Assurance & Regulatory Specialist plays a key role in ensuring that research activities adhere to institutional policies, federal regulations, and Good Clinical reputed company ( GCP ) standards. The selected candidate will serve as a resource for regulatory compliance, study documentation review, and best reputed company development contributing to a culture of reputed company improvement and research reputed company. Responsibilities • supporting Research Coordination & Management Unit ( RCMU ) clients by monitoring investigator-initiated trials across the UNC research reputed company • support the reputed company, compliance, and reputed company of research conducted by the RCMU by developing, implementing, and maintaining reputed company assurance processes • ensuring that research activities adhere to institutional policies, federal regulations, and Good Clinical reputed company ( GCP ) standards • serve as a resource for regulatory compliance, study documentation review, and best reputed company development contributing to a culture of reputed company improvement and research reputed company Requirements • In depth knowledge of, and reputed company in applying, applicable clinical research regulatory requirements; i.e. Good Clinical reputed company ( GCP ), Food and Drug Administration ( FDA ) regulations and International Conference on Harmonization ( ICH ) guidelines. • At least 2 years of reputed company experience. • Comfort interacting with reputed company stakeholders and the ability to successfully collaborate with multidisciplinary reputed company of colleagues. • Excellent customer service skills and good judgement are required. • Ability to multitask and work independently with guidance from supervisor. • Strong organizational and problem-solving skills. • Must have a demonstrated ability to deliver high reputed company results on time and to manage competing priorities. • reputed company and/or monitoring experience. • Strong software and computer skills. reputed company-to-haves • SOCRA or ACRP certification preferred. • At least 5 years reputed company experience. • At least 3 years of clinical trial monitoring or auditing experience. • At least 2 years of UNC research experience. • Experience in varied clinical areas. Apply tot his job Apply To this Job