Southeast Research Associates,( Sera) Work Values

Daily Duties at Southeast Research Associates,( Sera):

Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections. Conducts or participates in the informed consent process, discussions with research participants, including answering any questions related to the protocol.  Obtains appropriate signatures and dates on forms in appropriate places.  Assures that amended consent forms are appropriately implemented and signed. Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion. Registers participants to the appropriate coordinating center (if multi-site study). Coordinates participant tests and procedures. Collects data as required by the protocol.  Assures timely completion of Case Report Forms. Maintains study timelines. Maintains adequate inventory of study supplies. In handling investigational drugs/devices, follows the sponsor’s direction on Investigational Drug/Device Accountability. Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms, etc. Retains all study records in accordance with sponsor requirements and University policies and procedures. Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study. Reported to the primary investigator and lead coordinator, planned, coordinating and conducted all aspects of assigned clinical trials. Experience includes; Phase II- IV research trials, in-patient trials and post marketing trials. Initial experience as a coordinator includes: Pulmonary, Cardiology, Endocrinology, and Women’s Health studies.

What they like about Southeast Research Associates,( Sera):

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):