Senior Clinical Research Associate

Senior Clinical Research Associate (Sr CRA)

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.

Senior Clinical Research Associate (Sr CRA) is responsible for assigned tasks to support study planning, site training, following up and closing out open compliance related action items. A Sr CRA is expected to take a leadership role within the Clinical Team to be a resource for junior team members and main point of contact for Clinical Sites. This role is expected to foster and maintain a good working relationship with clinical sites from site identification, initial contact, site initiation through site close out.

Duties and 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

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

Working Conditions

• Position will be preferably based at Biolinq Headquarters (non-remote) or hybrid/remote as approved
• General office, Physician offices, Medical Clinics, Hospitals, and Laboratory
• Travel required up to 70% and will be based on number of clinical studies being conducted
• Hours of work may be outside of the traditional M-F work week

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee may occasionally lift/or move up to 15 pounds.

Benefits

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