Clinical Research Associate I

Biolinqorporated • San Diego, CA

1d • Onsite

About The Position

Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health. Job Purpose To support and contribute to the Clinical Affairs team execution and conduct of Biolinq sponsored clinical studies. Able to work under direct supervision of the Manager of Clinical Operations as well as collaboratively with other departments. Responsible for assigned tasks to support study planning and ensuring requirements are appropriately executed to meet deadlines, quality expectations, and priorities. A FCRA is expected to foster and maintain a good working relationship with clinical sites including addressing and resolving issues while ensuring their compliance with the study protocol and regulatory requirements.

Requirements

• Bachelor’s (BA or BS) degree in a STEM discipline, and 2-5 years of related experience or Master’s degree in a STEM discipline and 0-3 years of related experience
• Familiar with Good Clinical Practice guidelines and regulations for conducting human clinical studies
• Knowledge of the Health Insurance Portability and Accountability Act (HIPAA) and the ability to manage Protected Health Information (PHI)
• Complete tasks under minimal supervision
• Works on moderately complex problems where analysis of situations or data requires evaluation
• Exercises judgment within defined procedures and practices to determine appropriate action
• Demonstrates technical proficiency
• Personal computer skills, including proficiency in word processing, spreadsheet, and electronic databases
• Must maintain good communication skills with patients and health care professionals
• Ability to engage in continuous learning and self-development

Responsibilities

• Serves as a team member in all aspects of clinical study execution
• Provide clinical support with application and removal of a novel wearable biosensor device
• Act as a research coordinator or monitor for in-house studies and external studies including subject recruitment and follow-ups
• Maintain organization, timely ordering and shipping of supplies and equipment required for clinical studies
• Assist with the quality control of study-related documents and devices and be accountable for their correct distribution
• Assist with developing clinical study materials under direct supervision
• Coordinate study-related meetings and provide training to study staff and subjects at clinical sites
• Provide support to management for preparing documentation, reports, and presentations
• Conduct monitoring visits for Biolinq sponsored studies including completion of monitoring report and oversee any action items to completion
• Assist with distribution of regulatory documents and the maintenance of trial master files
• Assist with departmental audits of clinical studies and procedures
• Perform scribe function during clinical meetings and produce meeting minutes for management review
• Collaborate effectively with peers and leadership across departments
• Travel required up to 70%
• Other duties as assigned

Benefits

• Medical
• dental
• vision
• health savings account
• flexible spending account
• life and long-term disability insurance
• 401(k) plan
• holidays
• PTO

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level