About this opportunity
Ray Therapeutics, Inc. lists this Senior Clinical Research Associate opportunity in berkeley, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Ray Therapeutics mission is to restore vision to people with retinal degenerations. RayTx is using a novel bioengineered optogenetic protein optimized for human vision delivered by AAV to restore visual function in a mutation agnostic approach and without the need for light enhancing eyewear. The company is developing its lead candidate in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need as well as a pipeline to treat both rare and large market indications.
Reporting to the Senior Director, Clinical Operations, you will support the operational management of a current clinical trial. The key responsibilities of this role include oversight of the clinical trial at investigational sites to ensure data integrity, participant safety, and strict compliance with protocols and regulatory standards. Serving as a key point of contact for investigational sites, you will proactively manage site performance, recruitment, quality, risks, and issue resolution to ensure sustainable trial execution and high-quality data delivery.
Essential Duties and Responsibilities:
Perform site management and monitoring
Ensure adherence to Good Clinical Practice, ICH guidelines and company SOPs
Oversee electronic trial master file and investigator site files
Assist with vendor oversight by ensuring study documents/materials and oversight plans are being executed as written and updated where needed during the life of the study
Prepare study metrics for ongoing study team meetings
Track and provide weekly updates, issues, risks to the team
Prepare and assist in internal clinical meetings, tracking of actions, issues, and decisions
Maintain study-specific training records and ensure required training is documented and current.
Qualifications and Experience:
Bachelor’s degree in relevant scientific discipline required
4+ years of clinical research experience in a pharmaceutical or biotech company required with a strong understanding of clinical research and drug development processes
Prior ophthalmology, gene/cell or other similar complex therapy experience is preferred
Understanding of FDA regulations, ICH/GCP guidelines and medical terminology
Proficiency with Microsoft Office required
Excellent written and verbal communication, organization, and cross-functional collaboration skills required
Ability to manage multiple priorities and work independently
Ability to work hybrid schedule including 3 days per week in our Berkeley office
Ability to travel up to 35% to clinical sites
Compensation Range and Benefits:
For this role, the anticipated base salary range: $125,000 to $140,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
Ray Therapeutics also offers annual performance-based bonus, and a comprehensive benefits package.
At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.
All employment is decided on the basis of qualifications, merit, and business need.
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Worksite address
berkeley, CA, 94709, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.