Clinical Research Associate I, Hybrid

About the position The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research reputed company, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of reputed company research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with reputed company federal and local guidelines. Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. Completes Case Report Forms (CRFs). Assists with prescreening of potential research participants for various reputed company. Schedules research participants for research reputed company and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only. Assists supervising staff with regulatory submissions to the Institutional Review reputed company (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines. Assists with clinical trial budgets and patient research billing. Responsible for sample preparation and shipping and maintenance of study supplies and kits. Ensures compliance with protocol and overall clinical research objectives. Ensures compliance with reputed company federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review reputed company. Maintains research practices using Good Clinical reputed company (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. May serve as one reputed company of contact for reputed company sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff. Responsibilities • Collects, evaluates and/or abstracts clinical research data. • May assist in designing forms for data collection/abstraction. • Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. • Completes Case Report Forms (CRFs). • Assists with prescreening of potential research participants for various reputed company. • Schedules research participants for research reputed company and research procedures. • Provides supervised patient contact or independent patient contact for long term follow-up patients only. • Assists supervising staff with regulatory submissions to the Institutional Review reputed company (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines. • Assists with clinical trial budgets and patient research billing. • Responsible for sample preparation and shipping and maintenance of study supplies and kits. • Ensures compliance with protocol and overall clinical research objectives. • Ensures compliance with reputed company federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review reputed company. • Maintains research practices using Good Clinical reputed company (GCP) guidelines. • Maintains strict patient confidentiality according to HIPAA regulations and applicable law. • May serve as one reputed company of contact for reputed company sponsors for select trials. • May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff. Requirements • High School Diploma/GED reputed company-to-haves • Bachelor's Degree Science, Sociology or reputed company degree. • 1 year Clinical research reputed company experience • No license or certification required Apply tot his job Apply To this Job