ABOUT THE COMPANY:
Inflammatix, Inc. is a venture-backed diagnostics company bringing the power of precision medicine to the point of care. We are building novel diagnostic, prognostic, and predictive HostDx™ tests that combine rapid detection of host mRNA panels with advanced machine learning and computational biology. These tests will be performed on our rapid, point-of-care, isothermal molecular platform instrument currently under development. Our late-stage products, HostDx-Sepsis and HostDx-Fever, focus on enabling physicians to better diagnose acute infections and sepsis. Inflammatix is further developing a pipeline of groundbreaking tests that take advantage of our expertise in reading the immune system.
JOB DESCRIPTION: (Sr) Clinical Research Associate (West Coast)
We are seeking an experienced (Sr) Clinical Research Associate (West Coast) to play a key role in proactively supporting the conduct of clinical studies. The CRA will conduct site monitoring visits as well as perform in-house CRA responsibilities. This role will not be boring! Success will lead to increased exposure to advanced responsibilities and career growth opportunities. On the job learning and a desire to say “yes” to new things are expected. The candidate will report to the Head of Clinical Operations. This role has flexible working arrangements, with the option to work in the office or remotely.
- Preparation, conduct, and reporting of monitoring visits (pre-study, initiation, routine monitoring and closeout visit) per monitoring plan and applicable SOPs
- Provide protocol and related study training to assigned sites and serves as the main liaison to participating in clinical trial sites with a focus on data entry, query resolution, clinical sample shipment, recruitment, and overall site activity.
- Ensures the data cleaning process is performed and performs source data verification of study data entered into EDC.
- Collaborates regularly with study lead and clinical study sites to ensure timely delivery of study milestones
- Contribute to the preparation and amendments of study-related documents (informed consent forms, clinical trial agreements, budgets).
- Assists with organizing IRB/EC submissions with follow through to ensure successful outcomes.
- Participate in the development of project-specific documents (protocol, ICF), plans (e.g., Clinical Monitoring, Communication, etc.), and other study-related documents.
- May participate in vendor management, data management, or safety activities
- Maintain trial master file essential documents and clinical trial tracking systems.
- Ability to travel up to 70%
- BS degree in relevant field
- ACRP/CCRA or equivalent certification/credentials preferred
- 2-5 years of (CRA) monitoring experience in the pharma, IVD or CRO industry.
- Experience with EDC systems
- A thorough understanding of clinical processes, ICH, and associated regulatory guidelines
- Excellent verbal and written communication
- Knowledge of infectious disease or emergency or ICF medicine a plus but not required
- Excited to ‘wear many hats’ and self-motivated to take on new challenges
- Well organized and detail oriented
COMPENSATION AND CLASSIFICATION:
- Classification: Full-time position located at our Burlingame, California headquarters
- Compensation: Competitive and commensurate with experience; includes equity package.
- Benefits: Medical, dental, and vision; 401(k) and more.
HOW TO APPLY: Please forward a cover letter and resume to: email@example.com