Clinical Research Associate – Ophthalmology

Job Title: Clinical Research Associate – Ophthalmology

Job Number: 35339

Location: Remote, Remote

Job Description

The Clinical Research Associate is an important part of the team, responsible for monitoring studies, reviewing data, and working with sites to help ensure the smooth management of clinical trials.

Responsibilities

• Overseeing clinical studies for investigational and approved products, including site visits for various study phases such as qualification and closure.
• Training site staff on study protocols, documentation, and case report forms.
• Managing the supply of investigational products at sites, including preparation, tracking, and returns.
• Monitoring the dispensing, inventory, and reconciliation of study products.
• Overseeing the storage and shipment of laboratory samples.
• Reviewing and reporting on trial progress, including site updates, protocol deviations, adverse events, and lab results.
• Ensuring data accuracy and integrity by reviewing source documents and case report forms, and resolving data issues.
• Addressing data discrepancies and queries in collaboration with study sites.
• Checking regulatory documentation for completeness and supporting sites with regulatory matters.
• Keeping study files complete and up-to-date.
• Maintaining regular communication with study sites and involved parties.
• Following documentation standards and completing reports and correspondence as per procedures.

Required Skills

• High attention to detail.
• Strong organizational and communication skills, with effective problem-solving abilities.
• Ability to adapt to changing priorities.
• Efficient in managing and prioritizing multiple tasks.
• Familiarity with industry terminology and practices.
• Knowledgeable about relevant regulations and their application.
• Willingness to travel on short notice, including by air or car.
• Valid driver's license and access to a properly insured vehicle.
• Proficient in Microsoft Word, Excel, and PowerPoint.

Education and/or Experience:

• Degree in biological sciences or a related field, or equivalent experience.
• 2 years of prior experience in a similar role preferred.
• Experience in ophthalmology is advantageous.
• Salary range for this position is $85,000 to $140,000 per year.