Charlotte Gastroenterolgy And Hepatology Work Values

Daily Duties at Charlotte Gastroenterolgy And Hepatology:

• Managed multiple clinical trials providing adherence to study specific protocols, relevant regulations, Good Clinical Practice (ICH GCP E6) and FDA CFR part 21 • Conducted extensive medical record review and obtain medical history to determine if subject meets study protocol inclusion or exclusion criteria • Obtained participant informed consent • Oversaw study scheduling and served as primary contact for sponsors (CRO) • Participated in site selection (PSSV), study initiation (SIV’s), routine monitor visits (RMV) and close out procedures • Collected data and ensured datasets are completed and maintained according to regulatory requirements • Coordinated with principal investigator and study sponsor to ensure the integrity of clinical data in accordance to all applicable federal regulations, agency policies and standard operating procedures (SOPs) • Reported Adverse Events (AEs), Serious Adverse Events (SAEs) and Protocol Deviations to sponsor and IRB • Gathered and reported data utilizing multiple electronic and manual data collection systems • Dispensed trial related materials including Investigational Product (IP), as well as ensuring proper storage and accountability of IP • Maintained current competency with ongoing and continual regulatory and study specific training • Recruited potential study patients by educating physicians and colleagues regarding study specific inclusion and exclusion criteria • Participated in internal and external audit • Worked closely with sponsor, PCP, PI and subject to facilitate timely resolution of trial and/or clinical issues • Created and maintained data base to monitor new Hepatitis C treatment regimens and the associated Clinical Outcomes in standard clinical settings

What they like about Charlotte Gastroenterolgy And Hepatology:

The social vibrance of a hiring firm is very important to you. Your ability to make and maintain friendships there is a critical part of your decision. You would likely be dissatisfied with a workplace that is quiet, cold, or otherwise not particularly social. When you investigate a new hiring company, ask recruiters, managers, and potential co-workers about the social life and opportunities there. This is especially important when you are relocating; moving dramatically alters your social sphere both inside and outside the workplace.

Tags

Clinical Research Monitor, Regulatory Specialist, Case Management, Medical Management, Clinical Coordinator, Referrals Coordinator, Registered Nurse, Nephrology, Transplant, Clinical Research, Clinical Educator, Clinical Research Associate, Clinical Education Specialist, Clinical Outcomes Specialist, Clinical Integration Specialist, Disease Management, Project Management, Clinical Research Coordinator, Clinical Consultant, Clinical Nurse Liaison, ICH GCP E6, Clinical Implementation Specialist, EDC, IRB, Pharmaceutical, Rheumatology, Infectious Disease, Hepatology, Hepatitis, Gastroenterology (GI), IBD, IBS, Utilization Management

Skills

EDC system, Outlook, MS Word, Public Speaking, Educating

These are some of the questions we asked our climbers about their experiences with Charlotte Gastroenterolgy And Hepatology: