Spirair, a venture capital-backed medical device company, was co-founded by two Stanford Biodesign and Innovation fellows with a shared interest in optimizing outcomes and patient experience through innovation solutions. With a passion for developing elegant technologies that evolve care and enhance accessibility and effectiveness, the Spirair team is partnering with leading ENT advisors and industry veterans to offer treatment options that are both massively impactful and minimally invasive.
We are looking for a Clinical Research Associate based out of the Southern, Mid-Southern, or Western US who is within one hour of a major airport. (Ideal locations would be Texas or Chicago, IL.) This is a fully remote role.
The Clinical Research Associate (CRA) will perform Spirair sponsored pre- and post-market clinical studies. Support Clinical department in organizing and overseeing clinical studies, supervising study sites, collection, and authentication of study data. Must have demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations and experience with all phases of a study (qualification through final study report generation). Must have demonstrated problem solving skills, excellent communication, and demonstrate tactfulness and diplomacy in dealing with study teams.
MAJOR DUTIES AND RESPONSIBILITIES
- Perform independent monitoring of sites, including: conducting site qualification, initiation, interim monitoring visits, and close-out visits and finalize professional reports and follow up with sites according to company SOPs, monitoring plans and protocols.
- Maintain frequent contact with and work effectively with investigators and coordinators.
- Assist with clinical case support including device training and case proctoring for clinical research cases.
- Assist with management of site enrollment goals. For underperforming sites, identify barriers to enrollment and develop proposed solutions to increase recruitment.
- Manage trial master files for assigned projects including ongoing accuracy verification and final quality assurance review.
- Assist with document review of clinical protocols, case report forms, site study procedure manuals and project tools, monitoring plans, tracking tools, and informed consent forms.
- Set up and track documentation including clinical recruitment, subject status, documentation status and project status from clinical sites and/or CRO in excel and provide weekly reports for clinical team.
- Ensure all study supplies per protocol are ordered for all assigned projects.
- Coordination of internal and external conference calls, generation and review of minutes and action items from meetings.
- Review and resolve queries in clinical data with clinical sites.
- Assist Director and VP in review of clinical study reports, budget and contract negotiation.
- Perform clinical site invoice management and reconciliation.
- Conduct clinical site study supply management.
- Ensure regulatory compliance of investigational sites with company SOPs, FDA and ICH guidelines.
- Assist with Electronic Data Capture (EDC) database management.
- Support Director of Clinical Operations and Vice President, CA/RA/QA in ongoing projects as needed.
- Support the company Quality Policy and Quality System.
- Support company goals and objectives, policies, and procedures.
- Attend relevant clinical research professional meetings.
- Participate in recruitment / hiring of Clinical staff.
Preferred QUALIFICATIONS
Education and/or Job Experience:
- Bachelor's-level degree required. Degree in science/health/law-related field (e.g., Biology, Nursing, Public Health, Biomedical, Law) preferred.
- Experience in clinical research role or medical devices/pharmaceutical clinical trials, as well as working in a cross-functional product development setting. Four (4) or more years of monitoring experience preferred.
Skills, Abilities, and Requirements:
- Requires a high level of computer proficiency (Word, Excel, Outlook, PowerPoint, etc.).
- Possesses appropriate verbal and written communication skills for interacting with internal (Regulatory, Medical Affairs, Research & Development) and external stakeholders (Physicians, CROs, Medical Staff, etc.).
- Able to work and problem solve both independently and as part of a team.
- Able to work within deadlines as imposed by government regulations and internal milestones.
- Experience using electronic data capture (EDC) systems.
- Experience using SharePoint preferred.
- Ability to multi-task and prioritize with flexibility required in a fast-paced start-up environment.
- Travel may be required up to 75% during peak times.
Spirair offers highly competitive salaries, equity, and benefits, including medical, dental, and vision insurance, paid time off, and 401(k). Legal authorization to work in the US is required. We are not able to sponsor individuals for employment visas for this job. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment verification form upon hire.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
The expected base salary range for this role is $90,000 - $140,000. Compensation will be based on a variety of factors, including experience, qualifications, internal equity, and location.
