SpyGlass Pharma, Inc. logo
SpyGlass Pharma, Inc.

SpyGlass is developing novel treatments for chronic ophthalmic diseases.

Clinical Research Associate – All Levels

Location

California

Posted

4 days ago

Salary

$90K - $130K / year

Seniority

Mid Level

Bachelor Degree4 yrs expEnglishGoogle Cloud Platform

Job Description

• 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.

Job Requirements

  • Bachelor's 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.

Benefits

  • 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.
  • Share in our success with stock options, giving you a stake in the company’s future.
  • Annual Bonus opportunity.

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