Senior Clinical Research Associate

Ray Therapeutics, Inc.; Berkeley (CA); Hybrid; USD 125,000 - 140,000; Full time

Job summary

Ray Therapeutics, Inc. is seeking a Clinical Operations professional to support the management of a current clinical trial and ensure data integrity, participant safety, and regulatory compliance.

You will serve as a key contact for investigational sites, manage site performance, recruitment, quality, risks, and issue resolution to enable sustainable trial execution and high-quality data delivery. The role requires a Bachelor's degree in a scientific discipline and 4+ years of clinical research

Qualifications

• Bachelor’s degree in a scientific field.
• 4+ years of clinical research experience in pharma or biotech.
• Understanding of FDA regulations and ICH/GCP guidelines.
• Proficiency with Microsoft Office applications.

Responsibilities

• Perform site management and monitoring.
• Ensure adherence to GCP, ICH guidelines and SOPs.
• Oversee electronic trial master file and investigator site files.
• Assist with vendor oversight and study materials.
• Prepare study metrics for team meetings.
• Track issues and risks; provide weekly updates.
• Maintain training records and ensure current training.

Skills

Site management

GCP/ICH compliance

Regulatory knowledge

Communication

Cross-functional collaboration

Microsoft Office

Education

Bachelor's degree in scientific discipline

Tools

eTMF systems

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.