Clinical Research Associate, CRA II/Senior – Ophthalmology

This is a fully remote position, open to applicants in Alabama, +42 more states.

📋 Description

• Oversee clinical sites from the identification phase to the closeout stage.

• Conduct qualification visits, site initiation visits, monitoring visits, and termination visits at designated clinical sites.

• Prepare timely reports on visits and contacts.

• Act as the primary contact for assigned clinical sites.

• Address inquiries from sites and resolve issues to facilitate successful study execution.

• Ensure study integrity and foster relationships with investigators and site personnel.

• Review trial performance while protecting the rights, safety, and welfare of study participants.

• Collaborate with clinical sites to develop patient recruitment strategies that align with enrollment timelines.

• Guarantee adherence to standard operating procedures, study protocols and amendments, Good Clinical Practice, and relevant regulatory requirements.

• Assess the quality and integrity of reported data, site performance, and accountability of investigational products.

• Monitor the completeness and quality of regulatory documentation.

• Conduct verification of site documents.

⛳️ Requirements

• Minimum of 18 months of direct onsite monitoring experience as a Clinical Research Associate.

• Experience in monitoring ophthalmology clinical trials.

• Bachelor's degree or equivalent in biological science, pharmacy, or a related health discipline.

• Familiarity with Good Clinical Practice, relevant regulatory requirements, and clinical trial processes.

• Proficiency in using a Clinical Trial Management System.

• Experience with an Electronic Document Management System.

• Competence in Microsoft Office applications, particularly Excel and Word.

• Strong skills in site relationship management, problem-solving, and communication.

• Capability to work independently with a sense of urgency and minimal supervision.

• Client-oriented and adaptable approach to assignments with a commitment to continuous learning.

• Ability to juggle multiple priorities, assess evolving scenarios, implement study protocols, and adhere to project timelines.

• Ethical and patient-centered approach with a keen focus on quality and detail.

• Comfort in collaborating within a matrixed team and effectively communicating with both internal and external stakeholders.

• Excellent interpersonal, written, verbal, organizational, and problem-solving skills.

🏝️ Benefits

• Health, Vision & Dental Insurance.

• Tuition Reimbursement.

• Vacation, Holiday, and Sick Time.

• Flexible Spending & Health Savings Accounts.

• Work/Life Balance.

• 401(k) with Company match.

• Pet Insurance.

• Paid time off.

• Life insurance.

• Additional benefit offerings as per applicable plan terms.

• Some positions may qualify for extra incentives, bonuses, or other compensation programs.