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 :

Promoted to Quality Assurance Nurse Liaison; a newly created position at SERA. With the growth of staff and sites the position provided an in-house monitor. JOB DESCRIPTION: Functions as an expert research nurse coordinating single or multi-site trials. Provides direction in auditing and monitoring activities. Collaborates with multidisciplinary researchers to establish research studies that integrate new advances in clinical trials management. Develops and conducts patient and family education. Provides leadership and expertise in creating source documentation templates per specific protocols, corresponds with the sponsor to ensure study is on target. Conducts ongoing training of clinical trials staff, providing updated information on internal processes and resources and external benchmarks. For multi-site studies, ensures sites fully understand and comply with study protocol and provides training of site coordinators and/or supervision of site coordinators. Actively participates in planning and evaluation processes to improve and advance clinical research within the organization. Leads or chairs committees or task forces to address and resolve significant operational issues. Monitored 15% of each trial by the number of subjects enrolled for every study being conducted at SERA, including satellite sites. Trained, held staff accountable and recognized for applying GCP/ICH guidelines, clinical support, provided for every research coordinator and new investigator. Quality assurance program was successful in increased professionalism of the staff, professional confidence, and an increased cohesive environment at each medical specialty site. The site’s staff showed to be productive and profitable. Most recognized change --- useful working knowledge of the complex nature of the clinical research regulations. Trained appropriate staff in leadership qualities and positive management styles to support the research staff at each site with a “lead” coordinator. Assisted in developing and organizing the annual employee training program including; SERA’s SOPs, FDA Regulations and ICH-GCP guidelines; the training was set up in a “round table” discussion style to allow the coordinators who didn’t work together to interact while sharing their experiences per discussion topic. Disease and relative medical conditions were presented by guest speakers. The research staff seemed to always enjoy these training meetings. Clinical procedures were reviewed as new staff or as need indicated, certification in BLS was set up to keep staff current, documentation practices were reviewed; as well as, questions for the certification exam were used in a fun competitive game setting.

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

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

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 :