Emory University School Of Medicine Work Values

Daily Duties at Emory University School Of Medicine:

Successfully provided clinical trial workflow leadership and management for four biomedical trials (one Phase I, one Phase III international RCT, and two Phase IV QOL monitoring trials) and numerous academic research projects for surgery academic research subgroups and affiliated surgery faculty as sole division research project manager Specific Biological Specimen, Medical Device, and Investigational Product (IP) Experience: ● Received institutional IATA training for the safe, streamlined shipping of biological specimens (e.g. blood, urine, saliva, etc.) for pharmaceutical sponsor affiliated contracted labs (international-Canada) ● Prepared specimen collection kits for all enrolled/consented clinical trial participants o Collected biological specimens ● Acted as clinical trial liaison for all received investigational product from pharmaceutical company for direct distribution to enrolled clinical trial participants/patients through medical center’s Investigational Drug Service (IDS) Office ● Provided health education and instructions regarding IP use and adverse event reporting and symptom self-monitoring ● Coordinated clinical trial medical device receipt using current medical system purchasing systems (e.g. no charge POs) and departmental buying management/staff o Worked with medical center Investigational Drug Service (IDS) to set up IP receipt using IWRS system, accountability, recovery, and distribution as well as protocol training for pharmaceutical clinical trial o Coordinated sponsor monitoring visits for IP oversight and monitoring (e.g. storage, accountability, etc.) ● Experience working with domestic/international medical device sponsors and international pharmaceutical (UK) companies for providing on-site clinical trial management and oversight o Facilitated PI and sponsor monitoring and sponsor/medical liaison meetings for clinical trial progress monitoring ● Lead clinical trial start-up via site suitability process, IRB protocol and regulatory documents submission, and worked closely with pre/post award budgeting analysts with Emory Office of Research Administration (ORA) ● Revised and assisted with all FDA 1572 and annual IND associated reports for sponsor-investigator Phase I pharmaceutical trial ● Successfully maintained professional collaborations with two international sponsors, three internal clinical departments, numerous regulatory entities (federal, centralized, and institutional), patients and their families, and two CROs to ensure patient safety and protocol compliance ○ Initiated implementation of utilization of protocol and site specific participant welcome packet for patients and their families ● Worked with Office of Clinical Research to provide accurate protocol revisions for developing appropriate matrices distinguishing clinical and research activities for accurate sponsor billing ● Managed medical device log capture and facilitated all no-purchase orders through hospital supplies and receiving ● Managed all case report forms and associated regulatory binders to ensure accurate data collected and monitor discrepancies ○ Collected patient level data and entered all data into multiple electronic data capture systems (EDCs) ○ Monitored EDCs and produced and monitored associated queries for data reconciliation ○ Addressed any corrective actions and suggestions provided by sponsor and associated monitoring team ● Revised all academic research biomedical protocols for IRB submission for core and external surgery PI-led projects ○ Revised Data Safety Monitoring Board (DSMB) plans for associated biomedical protocols ○ Provided all IRB protocol amendments and associated revisions to ensure successful IRB approval status ● Performed all medical chart reviews for inclusion/exclusion criteria and research based informed consent processes in conjunction with PI and designated clinical team ● Facilitated contract negotiations with Office of Clinical Research and Office of Technology Transfer to increase budget for protocol training activities ○ Provided sponsor protocol training for 50+ surgery nurses and OR techs directly providing clinical management to PI and associated cases to increase protocol compliance in OR and increase patient safety ● Lead/co-facilitated monthly research meetings for endocrine surgery faculty ○ Facilitated inter-institutional de-identified data use agreement (DUA) for parathyroidectomy associated sexual health study with U. Pitt Office of Research and Emory Office of Compliance ○ Facilitated interdisciplinary scholar collaborations between endocrine research group and Emory and CDC affiliated health policy economists for cost-effectiveness study ○ Co-authored literature review chapter in neuropsychiatric symptoms management related to parathyroidectomy in surgery textbook (not yet published) ● Prepared all research meeting agendas for academic research subgroup ● Monitored and reported all adverse events and serious AEs to institutional review board and centralized IRB ○ Tracked all AEs and associated research clinic visits in internal tracking Emory Research

What they like about Emory University School Of Medicine:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

Tags

Skills

Clinical Research Project Management, Quantitative Data Entry and Analysis, STATA, Problem Solving and Leadership, Microsoft Office, Patient Interviewing and Conducting Research Informed Consent Process, Medical Chart Data Abstraction and Review, Survey Instrument Administration, Informed Consent and Regulatory Documentation Management, Active ICH-GCP and CITI Certificates

These are some of the questions we asked our climbers about their experiences with Emory University School Of Medicine: