Clinical Research Associate II - Hybrid

About This Role

This hybrid role involves coordinating and implementing increasingly complex research studies, working independently but in close collaboration with various supervising staff. The Clinical Research Associate II supports research objectives through tasks such as data collection, participant prescreening and scheduling, assisting with IRB submissions, and managing budget and billing. This position also serves as an independent contact for sponsors, the IRB, and research participants, and provides training to junior staff.

Responsibilities

• Work independently under minimal direction from supervising staff to coordinate and/or implement increasingly complex research studies
• Collect, evaluate, and/or abstract clinical research data
• Assist in designing forms for data collection/abstraction
• Enter and process clinical research data into Electronic Data Systems (EDCs) provided by sponsors
• Complete Case Report Forms (CRFs)
• Independently prescreen potential research participants for various clinical trials
• Schedule research participants for research visits and procedures
• Provide increasingly independent contact with research participants and/or conduct research participant visits independently
• Assist supervising staff with regulatory submissions to the Institutional Review Board (IRB)
• Work directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, Safety Letters, etc., in accordance with local and federal guidelines
• Assist with clinical trial budgets and patient billing
• Responsible for sample preparation and shipping and maintenance of study supplies and kits
• Ensure compliance with protocol and overall clinical research objectives
• Ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board
• Maintain research practices using Good Clinical Practice (GCP) guidelines
• Maintain strict patient confidentiality according to HIPAA regulations and applicable law
• Serve as the primary point of contact for external sponsors for select trials
• Respond to sponsor inquiries and attend meetings regarding study activities
• Participate in and provide training and education to other Clinical Research Associates
• Assist in coordinating activities of other associates to ensure compliance with protocol and clinical research objectives
• Participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
• Participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications
• Provide coordination of a minimal number of noncomplex research studies or projects independently