Clinical Research Associate I

Job Type Full-time Description    WARNING about fake job posting scams. There has been a recent wave of scams whereby third parties post fake job openings using a bogus email address that resembles xxxx@biolinq.com.  Under the guise of asking you to fill out an application, the scammers are attempting to gather your personal information.  See the Federal Trade Commission’s warning on this topic at:  https://consumer.ftc.gov/articles/job-scams The only official source for actual Biolinq job postings/openings is at www.biolinq.com/careers.  While other job sites (such as LinkedIn, Indeed or Glassdoor) may pull from Biolinq’s careers web page, you should visit www.biolinq.com/careers to verify the accuracy of the openings found on third party web sites.   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 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.   Duties and 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 Requirements Qualifications • 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   Working Conditions • Position will be based at Biolinq Headquarters (non-remote) • 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.  At Biolinq we fully subscribe to the principles of Equal Employment Opportunity. It is our policy to provide employment, compensation, and other benefits related to employment based on qualifications, without regard to race, color, religion, national origin, age, sex, veteran status, genetic information, disability, or any other basis prohibited by federal, state or local law. In accordance with requirements of the Americans with Disabilities Act and applicable federal, state and/or local laws, it is our policy to provide reasonable accommodation upon request during the application process to applicants in order that they may be given a full and fair opportunity to be considered for employment. As an Equal Opportunity Employer, we intend to comply fully with applicable federal, state and/or local employment laws and the information requested on this application will only be used for purposes consistent with those laws. To the extent required by applicable law, The Company maintains a smoke- free workplace.     As part of our efforts to ensure fair and equal pay based on merit, Biolinq supports pay transparency internally and during the recruitment process.  The U.S. base salary range reasonably expected to be paid for this role is: $70,000 to $85,000 per year.  We may ultimately pay more or less than the posted range.  Actual compensation packages are commensurate with experience and based on a variety of factors that are unique to each candidate including, but not limited to: skill set, depth of experience, education, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries for the job across the U.S.  The total compensation package for this position may also include an annual performance bonus and/or other applicable incentive compensation plans.  Biolinq also offers a comprehensive package of benefits including paid time off (vacation, holidays, sick time, parental leave), medical/dental/vision insurance, and 401(k) to eligible employees, subject to the terms and conditions of the applicable plans and any written agreement between the parties.  Your recruiter can share more about the total compensation package during the hiring process.   Please note: The information contained herein is not intended to be an all-inclusive list of duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.  If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Biolinq Talent Acquisition at Careers@biolinq.com  Salary Description $70,000-$85,000 per year