Clinical Research Associate (All Levels)

About SpyGlass Pharma:

At SpyGlass Pharma we are focused on improving and preserving the vision of patients suffering from chronic eye conditions while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common causes of blindness and getting these products to the patients that need them.

We have built a team of driven professionals with diverse expertise in ophthalmic products and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology and a history of commercial success. Our unifying mantra We create for patients doesnt just live on our walls but drives our decision making as we build the company creating the products processes and culture that make it happen.

This team has delivered a solid foundation of development and clinical data enabling over $200 million in funding to date with several top-tier venture partners. We are building confidence in the performance of our lead product going into Phase 3 clinical trials.

Summary:

The Clinical Research Associate (CRA) will join our Clinical Operations team in a hands-on role supporting the planning execution and monitoring of clinical trials. We are hiring across a range of experience levels and the title and scope of responsibilities may be adjusted based on background and expertise. This role is integral to the successful execution of our clinical trials serving as a primary point of contact for clinical sites and supporting patient-centered study conduct. The CRA will conduct monitoring visits build strong relationships with investigators and site staff and help ensure studies are executed with quality consistency and regulatory compliance across all phases of the trial.

Please note:This is a U.S. based remote position that requires regular travel to clinical trial sites across the country (up to 70%). Applicants must be currently authorized to work in the United States and comfortable with a travel-based schedule.

Essential Duties and Responsibilities:

• Conduct site monitoring visits (initiation routine and close-out) to ensure compliance with the clinical protocol GCP and regulatory requirements.
• Assist in the preparation and review of essential trial documents such as informed consent forms case report forms and investigator brochures.
• Collaborate with site staff to ensure proper documentation timely data entry and resolution of data queries.
• Assist in the identification selection and training of investigative sites.
• Maintain accurate and complete study files and records in accordance with GCP and company SOPs.
• Monitor study progress to ensure timelines and quality standards are met.
• Report site activities and findings to the Clinical Study Manager and escalate issues as necessary.
• Support regulatory submissions by preparing clinical trial applications and maintaining relevant documentation.
• Work collaboratively with cross-functional teams including Regulatory Affairs Quality Assurance and Project Management to achieve study objectives.
  

Qualifications Required for Position:

• Bachelors degree in life sciences nursing or a related field.
• Minimum of 4 years of experience in clinical affairs within the pharmaceutical or medical device industry with a preference on drug and drug/device combination products.
  
• Knowledge of GCP FDA/ICH guidelines and clinical trial monitoring practices.
• Strong organizational and problem-solving skills.
• Excellent communication and interpersonal skills with the ability to build strong relationships with investigative sites and internal teams.
• Proficiency in Microsoft Office and electronic data capture (EDC) systems.
• Ability to travel up to 50-75% domestically as required.

Why SpyGlass Pharma

• We are offering a range of $90000 - $110000 based on experience and qualifications along with an Annual Bonus opportunity.
• Share in our success with stock options giving you a stake in the companys future.
• Comprehensive health dental and vision insurance plans to keep you and your family healthy and happy with a variety of plan and coverage options.
• Generous paid time off including holidays vacation days and personal leave.

SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity marital or veteran status disability or any other legally protected status.

SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to and let us know the nature of your request and your contact information.

Required Experience:

Senior IC