Clinical Trial Coordinator

Overview

Black Canyon Consulting (BCC) is searching for a Clinical Trials Coordinator to support our work for the National Center for Biotechnology Information (NCBI) at the National Library of Medicine (NLM), an institute of the National Institutes of Health. This opportunity is full time and onsite at the NIH-NCBI in Bethesda, MD and/or remote work.

The National Center for Biotechnology Information (NCBI) is part of the National Library of Medicine (NLM) at the National Institutes of Health (NIH). NCBI is the world’s premier biomedical center hosting over six million daily users that seek research, clinical, genetic, and other information that directly impacts biomedical research and public health – at NCBI you can literally help to accelerate cures for diseases! NCBI’s wide range of applications, platforms (node, python, Django, C++, you name it) and environments (big data [petabytes], machine learning, multiple clouds) serve more users than almost any other US Government Agency according to https://analytics.usa.gov/.

You will join NCBI’s team of web developers and software engineers to build robust, flexible web applications, APIs, and services. This role calls for an expert web developer – with knowledge and experience in modern web development, testing, UI design and usability principles, and ability to work effectively with user researchers, designers, product managers, scientists, security and DevOps engineers.

Duties & Responsibilities

• Assist with the development of protocol, policies, and procedures

• Assist with documentation and training of new staff on protocol procedures and required competencies

• Participate in protocol development, audits, and required reporting to regulatory bodies and intramural research programs

• Ensure compliance with FDA and IRB requirements for IND protocol

• Provide agendas for weekly team meetings and record minutes as needed

• Contribute to scientific and technical writing including documentation, checklists, and contribution to protocol and manuscripts

• Collaborate on related projects, particularly with shared equipment, purchases, and clinical needs

• Monitor study progress and develop benchmarks to ensure performance goals are met

• Develop and maintain spreadsheets to track study progress

• Maintain data and records in compliance with NIH policies and ensure integration with other data systems

• Create training materials and track training, including equipment and techniques

• Perform lab research, record, and analyze data, including documentation of test results

• Ensure adherence to timelines

• Document progress using electronic lab notebooks

• Prepare summaries and reports

• Submit orders for supplies, equipment, and training using NIH systems (e.g., POTS)

• Meet weekly with PI, lab members, and clinical staff

• Communicate with prospective research participants, perform telephone screens, and work with NIH staff to determine eligibility

• Coordinate subject payments, eligibility, calendars, etc.

• Complete required clinical trainings and training for study-specific procedures

Benefits and Salary

We attract the best people in the business with our competitive benefits package, including medical, dental, and vision coverage; a 401(k) plan with employer contribution; paid holidays, vacation, and tuition reimbursement.

We offer a competitive salary commensurate with experience and location. If you enjoy being part of a high-performing, professional, technology-focused organization, please apply today!