Senior Clinical Research Associate

Biolinqorporated•San Diego, CA

6d•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.

Requirements

Bachelor’s (BA or BS) degree in a STEM discipline, and 3-5 years of related experience or Master’s degree in a STEM discipline, and 2-4 years of related experience
Certification and/or Training in Clinical Research preferred.
Knowledgeable in Good Clinical Practice guidelines and regulations for conducting human clinical studies
Experience complying with Health Insurance Portability and Accountability Act (HIPAA) and the ability to manage Protected Health Information (PHI)
Independently completes routine work with management input on tasks of greater complexity.
Provide leadership to junior team members of Good Clinical Practice.
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

Serve as a team member in all aspects of clinical study execution
Provide on-site lead clinical support from execution to compliance
Serve as an accessible resource for clinical site to answer protocol and study logistics related questions
Act as a clinical study monitor for in-house and external study protocols
Maintain organization systems for tracking site progress throughout clinical trial
Learn and consistently complete work that is in line with Biolinq Clinical Procedures.
Develop clinical study materials with management input.
Run 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
Other duties as assigned