In-House Clinical Research Associate I (contract to hire)
Job Title: In-House Clinical Research Associate (Contract Role)
Description: We are seeking a Clinical Research Associate (CRA) to support our clinical operations team at Diassess Inc. This position will participate in the planning, development and execution of clinical trials to evaluate the safety, effectiveness and performance of diagnostic medical devices. The CRA will support study activities to meet protocol and company objectives, maintain regulatory compliance, and maintain professional integrity for clinical trials. This position is based in our Emeryville, CA office with the potential for up to 15% travel.
About Us: Diassess is a startup striving to transform the way infectious diseases are diagnosed. We are developing a disposable home-use test which yields results within 30 minutes. This technology bypasses centralized medical lab testing and streamlines patient care. Our current areas of focus include respiratory diseases and women’s health.
Our Vision: Healthcare costs are 18% of USA GDP, 30 million Americans are uninsured, and in some regions of the world, healthcare is nonexistent. Our company is addressing these problems by making medical diagnostics more affordable and more accessible. Ideal candidates will share our vision and passion for improving healthcare in the U.S. and around the world.
Primary Job Function:
- Performs site monitoring visits (SIV, IMV, Close-Out) and site management activities to assess the site’s ability to effectively and continuously conduct the trial per the protocol, GCP, and regulatory requirements
- Manages clinical study database, including ensuring the integrity of the data submitted on Case Report Forms (CRFs) by careful source document review and monitoring
- Tracks the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample tracking
- Files documents in the Trial Master File (TMF)
- Generates project plans, especially those related to site management, monitoring and reporting
- Manages and tracks clinical and non-clinical supplies, including purchase and shipping
- Works closely with other clinical team members and external partners, e.g. CROs and vendors, to facilitate timely resolution of trial and/or clinical issues
- Identifies and evaluates additional resources necessary for regulatory and clinical projects
- Understands FDA guidelines as well as Good Clinical Practice (GCP)
- Promotes the values and ethics of our company through all interactions with teammates and potential collaborators, customers, and vendors
Education: Bachelor’s or master’s degree in science, nursing, or equivalent
Skills: The ideal candidate will possess most of the following skills and will be excited to learn the rest:
- 2+ years clinical research experience in medical/diagnostic device or pharma with independent clinical monitoring experience
- Experience with electronic data capture (EDC) systems, trial master files (TMF), electronic medical records (EMR), and clinical trial databases/clinical data management systems
- Strong verbal and written communication skills
- Excellent organizational, record retention, time management, decision-making, customer service, multi-tasking and interpersonal skills
- Knowledge of FDA and global regulation of medical devices, e.g. PMA, 510(k), IDE, CLIA waiver, CE Mark
- Experience with establishing or working with a quality management system (QMS)
- Ability to work independently and collaboratively to find creative and resourceful solutions to problems
Diassess is an Equal Opportunity Employer.
Individuals seeking employment at Diassess are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation