Senior Clinical Research Associate

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About the Company

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 Description

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