Senior Clinical Research Associate

Los Angeles, CA  ·   Full Time

About our Company

Founded in 2013, NovaSignal Corp. is a medical technology company whose mission is to save lives by unlocking the hidden power of blood flow data. We get up every day with the goal of making the world a better place by improving the lives of people suffering from brain driven diseases such as stroke. Our FDA-cleared, AI-driven, robotic ultrasound system is revolutionizing healthcare and will help millions of people across the globe as we continue to expand our reach. We are looking for people to join our rapidly growing team who are not afraid to roll up their sleeves, get to work, and make a difference in the world!

If you are someone who is looking to make a big impact, partner with outstanding talent, and take your career to the next level, we encourage you to join us! You would be an excellent fit if you pride yourself in being a self-starter, adaptable, highly organized, big thinker, analytical, and have a strong eye for detail.

About the Role

The Senior CRA will serve as the liaison between clinical sites and NovaSignal. Working closely with the Clinical Program Manager (CPM), you will prepare and execute clinical trials ensuring that all study deliverables are completed per Sponsor and study timelines.

As the Senior CRA, you will

• Participate in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
• Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF, monitoring expectations and study close-out activities.
• May assume the role of Clinical Project Manager as required: It is the responsibility of the CPM to ensure that activities associated with clinical trial planning and start-up are completed.
• Develop investigator agreements (e.g., NDA, CTA, etc.) and study/site budgets within fair market value (FMV) and negotiates CTA/budget with sites to full execution.
• May review and develop protocols, eCRFs, informed consent forms, study manuals and other study-related plans and documents, as requested by the  Clinical Project Manager (CPM).
• Assist with processing of subject visit payments to clinical sites and study vendors/committees.
• Maintain Trial Master File (TMF) to ensure all essential documents are collected, reviewed and filed in preparation for Sponsor or site audits by FDA or other Competent Authorities.
• Manage investigational product inventory at investigative sites overall study product accountability.
• Coordinate activities with the site in preparation for the initiation of the study. Works with site staff to obtain regulatory (IRB/IEC) approval of study specific documents.
• Attend study-related, company, departmental, and external meetings, as required and prepare meeting agendas and minutes for distribution.
• Ensure internal and external study team trainings are completed per company and department training matrix and study-specific Project Operations Manuals (POM).
• Perform other duties, as requested.

What you bring

• BS/BA/BSc (or equivalent) and a minimum of five (5) years of In-House CRA/CTA, site management, or CRC experience is required; or equivalent combination of education, training and experience.
• Knowledge of coordinating and conducting clinical trials at the Sponsor level.
• Knowledge of clinical research and development processes, including working knowledge of all functional areas of clinical trials and medical terminology.
• Computer literacy and knowledge of electronic data capture required.
• Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
• Excellent presentational, organizational and interpersonal skills.
• Proven success in maintaining or exceeding study enrollment goals and timelines.
• Proven track record in delivering clinical projects on time, within budget, and in compliance with SOPs and regulations.
• Ability to handle several priorities within multiple, complex trials.
• Understanding of current GCP/ICH guidelines applicable to the conduct of clinical research.
• Prior monitoring experience preferred.

EEO Statement

NovaSignal is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

DISCLAIMER

NovaSignal does not accept unsolicited resumes from search firm recruiters. Fees will not be paid in the event a candidate submitted by a recruiter without an agreement in place is hired; such resumes will be deemed the sole property of NovaSignal.

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