Clinical Research Associate I, Butte Lab

About the Role

Dr. Pramod Butte, Ph.D. is looking for a Clinical Research Associate I to join a diverse team focused on translational research in bio-photonics. The laboratory is developing novel intra-operative imaging/visualization technologies to aid surgeons in achieving near-complete tumor excision. This role offers an outstanding opportunity to work with a multidisciplinary team and be involved in the development and possible commercialization of a novel medical device technology.

Key Responsibilities

• Schedules patients for research visits and research procedures.
• Enters clinical research data into Electronic Data Systems (EDCs).
• Provides supervised patient contact or patient contact for long-term follow-up patients.
• Assists with regulatory submissions to the Institutional Review Board (IRB), including Adverse Events, Serious Adverse Events, and Safety Letters.
• Responsible for sample preparation and shipping, and maintenance of study supplies and kits.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs.
• Obtains patient consent, if authorized, to participate in clinical study.
• Engages with OR staff to ensure informed, accurate, and timely transport, scanning, and processing of specimens.
• Works with, handles, and processes fresh and fixated specimens per outlined protocol.
• Performs scanning of specimens using clinical prototypical imaging device(s).
• Performs transport, set-up, and tear-down of clinical equipment used in the clinical study.
• Evaluates and abstracts research data and ensures compliance with protocol and research objectives.
• Completes case report forms.
• Provides limited patient contact as needed for study.
• Assists with study budget and patient research billing.
• Follows all federal, local, FDA, IRB, and HIPAA guidelines and regulations.

Requirements & Tech Stack

• Understanding of general research objectives.
• High School Diploma or GED, required.
• Experience in a clinical research setting is highly preferred.
• Interest or experience in a start-up environment with an entrepreneurial spirit is highly desired.
• Experience working with a multidisciplinary team.
• Experience with clinical trials.
• Experience collecting clinical data.
• Experience in developing clinical protocols.