Atlanta Gastroenterology Associates Work Values

Daily Duties at Atlanta Gastroenterology Associates:

Provided support to ensuring relationship with site(s) is positive, issues are resolved quickly, and communication is strong across all verticals. Developed a plan for each trial to realize goals, time management reviewed with each staff member for maximize productivity, drove patient recruitment, ensured enrollment and compliance to protocol. Provided training to research staff covering the protocol with investigator, included a thorough review of the inclusion/exclusion criteria, created tools to ensure study visits and the timeline of each visit, reviewed prohibited concomitant medications, study conduct, CRF completion, and data management expectations. Performed regulatory submission for all research studies. Submitted all essential documents for study start-up to sponsor, CRO and the IRB for all research studies. Negotiated budgets for all clinical trials; realizing on average a 25% or more increase from sponsor’s initial budget offer. Reviewed and negotiated contracts for all clinical trials. Invoiced sponsors per contracts and performed final reconciliations of study contracts to payments received. Served as a liaison between the primary Investigator, Sub-Investigators, research staff and office staff at each site/medical office where participants were seen per IRB approval. Participated in hiring and fully responsible for the training of a new hire, providing GCP, job and study specific training. Organized, planned, and executed the yearly formal training for the research staff at the sites/ medical offices in which management provided Conducted quality assurance monitoring for sites to ensure compliance with ICH/GCP guidelines, and FDA regulations, study protocol criteria, and AGA SOPs. Managed multiple studies and coordinated all aspects of specific trials. Monitored Investigational product or device supplies and accountable for compliance and/ or non-compliance, documenting any issues, as well as communicating with the CRO or sponsor. Mentor, coach and provide guidance to clinical staff as appropriate. Supervised and trained new Investigators or Sub-Investigators as needed. Reported areas of need or areas of performance improvement to Primary Investigator. Reviewed yearly AGA, Standard Operating Procedures; updating, adding, or deleting as assessed appropriate with communication of all the Investigators, and other lead coordinators, as it involves their site. Communicated with Primary Investigators and Sub-Investigators throughout each trial as well as the other CRCs or data coordinators. Developed strong working relationships with the CRO or monitor of each trial and the Sponsor of each project.

What they like about Atlanta Gastroenterology Associates:

Organizations with strong, centralized leadership are particularly attractive to you. You require a work environment with leadership that aggressively seeks to expand and grow the business and does so in a visible and decisive manner. In general you prefer to work in an environment in which there is a strong link between leadership, its actions, and a strong set of company-wide values.

Tags

Certified Clinical Research Coordinator, Internal Quality Assurance, Trainer clinical research, GCP/ICH, & FDA regulations, Regulatory, Budgets and Contract Negotiation, Project management, Certified Clinical Research Nurse, Clinical Research Nurse , Internal Quality Assurance/Monitoring, Educator and trainer in Clinical Research, 15 years experience in conducting phase II-IV drug trials. Post marketing registry experience as well., Quality Assurance, internal monitor for a large multi-speciality research organization, included 8 research sites in the greater Atlanta area, Developed training program, executed a yearly training in GCP/ICH guidelines and FDA regulations, as well as site SOPs., Negotiated all contracts and budgets for every study at research center in the last 8 years, organized all aspects of awarded studies. High enroller and recognized for quality data with a turn around of data to sponsor resulting in consulting with sponsor for future studies., Registered Nurse, certified clinical research coordinator. first study personal conducted 85 subjects were enrolled.

Skills

Skill #1: Subject/patient assessment-- physical, emotional, and psychological status/ accurate documentation.

These are some of the questions we asked our climbers about their experiences with Atlanta Gastroenterology Associates: