Southeast Research Associates,( Sera) Radiant Research, (Atlanta West), Formerly Protocare, Inc. Formerly Work Values

Daily Duties at Southeast Research Associates,( Sera) Radiant Research, (Atlanta West), Formerly Protocare, Inc. Formerly :

15-20 Direct Reports Organized, communicated and evaluated the research team objectives for each clinical study. Met with research staff, encouraged the coordinator’s ideas and thoughts to create a plan per study project, timelines identifying critical data points, per protocol. Called coordinators to lead in developing study-related documents, checklist, logs, and or source documents. Creating documents, increases knowledge of the protocol. Focused to train and build the research staff’s responsibility and reassure them they are a professional staff, they have good ideas for the way they see the study project working the best. Checked all the informed consent prior to approval by the IRB to ensure its understandability for the subjects. Reviewed invoices from study vendors, institutional review board approvals, and clinical study agreements along with the monitoring reports. Supervised and assessed the performance of the clinical research staff and provided training as indicated. Served as a liaisons between study sponsors, CRO, investigative sites and the monitors to maintain a good understanding of the center and the quality of the data being submitted. With seven satellite sited as well as the main pulmonary site, it was necessary to keep the lines of communication open with all individuals involved in the study. Created and delivered annual strategic operation and annual business plan. Provided appropriate staffing, marketing development, staff support feedback, recognition areas of excellence and redirection of goals per needs of the sponsor

What they like about Southeast Research Associates,( Sera) Radiant Research, (Atlanta West), Formerly Protocare, Inc. Formerly :

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 Southeast Research Associates,( Sera) Radiant Research, (Atlanta West), Formerly Protocare, Inc. Formerly :