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):

A hiring company that offers alternative approaches to pay, performance bonuses, and/or equity in the firm is very attractive to you. You're generally less interested in working for an organization offering only traditional, salary-based compensation, one with limited opportunity to acquire equity in the firm, or one that does not actively promote skill development. In addition, you are more likely to choose a company that offers a variety of internal career options, with defined career paths. You view the learning of new skills and development of your expertise as key to your career advancement. These aspects of an organization may become even more important to you as you progress in your field, and are especially critical if you change career or occupation.

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):