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 :

Direct Report: Research Site Director Job description Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections. Assists PI in communication of study requirements to all individuals involved in the study.  Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log. Collects documents needed to initiate the study for submission to the sponsor (e.g., FDA Forms 1572, CVs, etc.). Works with the PI to develop and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals. The following are examples of the” hands- on” initiative: scheduled one-on-one time to train, support and observe staff. Conducted or participated in the informed consent process including interactions with the(IRB), 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. Screened subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion. Coordinated participant tests and procedures. Collected data as required by the protocol.  Assures timely completion of Case Report Forms. Maintained study timelines. Maintained adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor and/or AGA's Investigational Drug/Device Accountability. Completed study documentation and maintains study files in accordance with sponsor requirements and AGA 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 AGA policies and procedures. Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study. Objective of promotion The goal and challenges of the created clinical model was discussed and identified during the managerial meetings included the development discussions of a multi-specialty site management organization. Though a SMO was a lofty goal, assessed as an endeavor in the research industry that would stand a part Worked with director, medical director, and monitors, to manage and organize multiple tasks related to various clinical studies. Ensured study milestones are met and completed according to protocol, project budget, regulations and company SOPs. Managed internal clinical operations activities to ensure all are executed according to protocol and in compliance with industry standards. Responsible for all client liaison activities with a tool of measure for customer satisfaction, maintaining extensive client communication, and overall management of client relationships. Provided quality data through multispecialty Site Management Organization with an emphasis as a Center of Excellence, was successful to the research industry. Developed a training program which produced professionally, well - trained research CRCs and administrative staff, with a culture that held-up quality health care and patient safety. Incorporated private medical practice physicians,which increased accurate data collection with strong documentation of medical history, medication use, procedures, etc. The model was created from the background of a professional Nurse with the ethical principles of the Code of Nursing, which aligns with the very nature of a strong research site’s attributes. The site was effective in marketing the organization.

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

Working for a company with an emphasis on social values and helping society is a clear and important priority for you - a critical factor in who you choose to work for. In contrast to other factors, you place an organization's reputation for fairness and concern for the community above most other aspects of the company. As you search for a new job opportunity, it is usually possible to find out if the company is involved in the community and/or if it is addressing problems and issues in society. Pay special attention to non-profit organizations and those specifically involved in social action. Moreover, speaking with current and former employees should enlighten you to perceptions of the fairness of the company's leaders and the treatment of employees.

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 :