Senior Clinical Research Associate (Ophthalmology)
About The Position
We are seeking an experienced Senior Clinical Research Associate (Ophthalmology) to join our growing Clinical Operations team. In this role, you will serve as the primary liaison between investigative sites and project teams, ensuring the highest standards of quality, ethics, and regulatory compliance. You will work on innovative oncology studies, primarily in early-phase development, and help drive operational excellence across site management activities. This position offers the opportunity to work on cutting-edge oncology programs, collaborate with global teams, and contribute to meaningful therapeutic advancements.
Requirements
- BA degree or RN or higher, preferably in sciences/medical sciences, or equivalent experience.
- Minimum of 5 years of clinical monitoring experience in pharma, CRO, or site-based settings.
- Ophthalmology monitoring experience required, preferably in Phase I/II studies.
- Willingness and ability to travel up to 30% as required by project timelines.
- Strong knowledge of ICH-GCP guidelines and regulatory requirements.
- Experience with CTMS, EDC, eTMF, and other clinical systems preferred.
- Excellent attention to detail and organizational skills.
- Excellent Visual acuity - Including color perception, depth perception, and field vision. Close visual acuity is necessary for tasks such as preparing and analyzing data, transcribing, and extensive reading.
Nice To Haves
- Oncology and dermatology experience is strongly preferred and will be considered a significant advantage.
Responsibilities
- Conduct monitoring visits (Pre-Study, Initiation, Interim, and Close-Out) to ensure trials meet ICH-GCP, protocol, and regulatory standards.
- Verify accuracy of source data, eCRFs, and essential documents for assigned study sites.
- Identify and resolve protocol deviations, data inconsistencies, and site compliance issues.
- Serve as the primary contact for research sites, maintaining strong communication with investigators and sponsor teams.
- Prepare and submit monitoring reports and follow-up documentation within required timelines.
- Maintain accurate study records in CTMS, eTMF, and other tracking systems to ensure inspection readiness.
- Support investigator meetings, training, and study start-up activities.
- Ensure timely reporting of adverse events (SAEs/SUSARs) per sponsor and regulatory guidelines.
- Contribute to quality assurance, audits, and continuous process improvement initiatives.
- Develop therapeutic area expertise and mentor junior CRAs as needed.
Benefits
- Insurance including Medical, Dental & Vision with significant employer contributions
- Employer-funded Health Reimbursement Account
- Healthcare & Dependent Care Flexible Spending Accounts
- 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance
- 401k plan with generous employer match
- Access to an Employee Assistance Program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
