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 ResponsibilitiesServe as a team member in all aspects of clinical study executionProvide on-site lead clinical support from execution to complianceServe as an accessible resource for clinical site to answer protocol and study logistics related questionsAct as a clinical study monitor for in-house and external study protocolsMaintain organization systems for tracking site progress throughout clinical trialLearn 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 sitesProvide support to management for preparing documentation, reports, and presentationsConduct monitoring visits for Biolinq sponsored studies including completion of monitoring report and oversee any action items to completionAssist with distribution of regulatory documents and the maintenance of trial master filesAssist with departmental audits of clinical studies and proceduresPerform scribe function during clinical meetings and produce meeting minutes for management reviewCollaborate effectively with peers and leadership across departmentsOther duties as assignedRequirementsBachelor'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 experienceCertification and/or Training in Clinical Research preferred.Knowledgeable in Good Clinical Practice guidelines and regulations for conducting human clinical studiesExperience 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 evaluationExercises judgment within defined procedures and practices to determine appropriate actionDemonstrates technical proficiencyPersonal computer skills, including proficiency in word processing, spreadsheet, and electronic databasesMust maintain good communication skills with patients and health care professionalsAbility to engage in continuous learning and self-developmentWorking ConditionsPosition will be preferably based at Biolinq Headquarters (non-remote) or hybrid/remote as approvedGeneral office, Physician offices, Medical Clinics, Hospitals, and LaboratoryTravel required up to 70% and will be based on number of clinical studies being conductedHours of work may be outside of the traditional M-F work weekPhysical RequirementsWhile 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.BenefitsMedical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.