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Pharmaron · 2 days ago

Senior Clinical Research Associate (Ophthalmology)

United States

Full-time

Hybrid

Senior Level

$110K/yr - $125K/yr

5+ years exp

Pharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. They are seeking an experienced Senior Clinical Research Associate (Ophthalmology) to serve as the primary liaison between investigative sites and project teams, ensuring the highest standards of quality, ethics, and regulatory compliance while working on innovative Ophthalmology studies.

BiotechnologyChemicalPharmaceutical

No H1B

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

Qualification

Ophthalmology monitoringClinical monitoring experienceICH-GCP guidelinesCTMS experienceEDC experienceETMF experienceVisual acuityAttention to detailOrganizational skillsMentoring skills

Required

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

Willingness and ability to travel up to 30% as required by project timelines

Strong knowledge of ICH-GCP guidelines and regulatory requirements

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