Clinical Research Associate

Newport Beach, CA         ·       Part time

About the job

Wave Neuro is the leader and authority in Braincare seeking to redefine the way cognitive health is understood and how mental health is managed. We develop technologies that empower and overcome barriers without pharmaceuticals or invasive procedures, technologies that are more accessible, more understandable, more viable, and more affordable. We serve people, not patients and combine decades of medical research with targeted methodologies to create access to better healthcare. Wave Neuro’s vision is to empower others to understand their unique brain and become their best selves. We have innovated a method that improves non-invasive neuromodulation technology to address a wide range of neurological disorders, as well as enhance cognitive performance, using non-pharmacological methods. The technology is a precise, personalized therapy that analyzes brainwave activity using machine-learning and helps guide decisions on treatment stimulation parameters

Job description:

The Clinical Research Associate will assist the Clinical Research Manager in studies to evaluate the performance, safety, and efficacy of products, and meet applicable regulatory standards. Under direct supervision, the Clinical Research Associate will serve as a clinical trial site manager, junior project manager, and will provide the clinical research department with support for current and planned studies.

• Support conduct of registered and non-registered clinical studies of medical device and general wellness products, ensuring compliance with study timelines, milestones, and applicable regulations.
• Execute operational aspects of clinical trials in conjunction with project teams, and in accordance with standard operating procedures (SOP), Good Clinical Practice (GCP) and applicable regulations.
• Lead site initiation activities, resolution and follow-up of site issues, and study closure.
• Lead the development and maintenance of clinical trial documents (e.g., study protocol, informed consent, case report forms, manual of procedures); may require direct contribution.
• Provide support and training for clinical study sites to assure data integrity and protocol compliance.
• Work closely with trial sites to mitigate issues.
• Provide site status reports to project manager.
• Maintain registration on www.clinicaltrials.gov from study initiation through posting of results.
• Provide supporting role in planning grant application and submission.
• Organize and maintain regulatory documentation and records in electronic file management system.
• Serve as compliance officer for clinical trial regulatory functions.
• Lead site meetings with trial personnel (e.g., study coordinators).
• Administrative functions, to include scheduling meetings, and recording and distributing meeting notes.
• Assist clinical research management team on other projects, as needed.

Minimum requirements:

• Bachelor’s degree plus 3-5 years of clinical trial experience OR Master’s degree plus 1-3 years of clinical trial experience
• Associate’s degree pus 8-10 years of clinical trial experience may be considered.

Preferred experience:

• Degree in life sciences, engineering or related medical/scientific field
• Experience with IDE clinical trials
• Experience with Class I/II medical devices
• Knowledge of FDA and GCP regulations
• Knowledge of neuroscience and/or mental health disorders

Skills/Abilities:

• Ability to read and understand clinical trials protocols
• Ability to work well in a dynamic, fast-paced environment
• Ability to shift priorities and plan work based on department needs
• Capable of working on multiple projects in a deadline-driven environment
• Demonstrated skill under pressure
• Able to work independently and as a member of a team
• Results-oriented and strong sense of urgency
• Accuracy and attention to detail are essential
• Excellent interpersonal and communication skills
• Excellent organizational skills
• Eagerness to learn and grow within role

Please click here to apply.