Clinical Trial Associate II

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide support to Project Managers and study teams in the execution of clinical studies for ophthalmic projects.

• Assist with study feasibility, manage site contracts and budgets, gather regulatory documents, coordinate patient visit scheduling, and ensure compliance with GCP protocols.

• Guarantee that study documentation, communication, training, and data collection are in accordance with protocols, SOPs, regulations, and guidelines.

• Oversee the creation of study-related documents, such as informed consent forms, source documents, and study logs.

• Engage in the management of clinical trial sites from the initiation phase through execution and closeout.

• Collect and assess site regulatory documents for precision and completeness.

• Prepare essential document packages necessary for investigational product release, site approval, continuity reports, and closeout submissions.

• Develop regulatory packages for IRB/IEC submissions related to studies and sites.

• Compile and distribute regulatory binders and provide Investigator Site File trackers for monitoring visits.

• Assist project management through the creation of meeting minutes, agendas, weekly newsletters, and tracking systems for clinical studies.

• Support the preparation of study reports, updates on site status, and metrics for studies.

• Establish, maintain, and ensure quality control for Trial Master Files/electronic Trial Master Files and file-sharing platforms.

• Participate in Study Operations planning, discussions on risk assessment, and pre-study meetings.

• Facilitate process improvement initiatives, SOP reviews, and departmental training.

• Aid in audit preparations and responses to audit findings.

• Comply with Ora's quality system, data integrity, business ethics, and regulatory standards.

⛳️ Requirements

• A Bachelor's degree with at least 1 year of experience as a clinical trials associate; relevant years of experience may substitute for the degree.

• Strong preference for candidates with ophthalmic experience.

• Capability to work independently and within a semi-virtual, cross-functional team environment.

• Proficient analytical and problem-solving skills.

• A consistent sense of urgency accompanied by acute attention to detail.

• Knowledge of GCP/ICH regulations is essential.

• Experience in maintaining electronic trial master files.

• Strong verbal and written communication skills.

• Exceptional organizational and time management abilities to handle multiple trials, critical tasks, and process improvement initiatives.

• Capable of remote problem-solving with site staff.

• Travel requirements are less than 10%.

🏝️ Benefits

• Comprehensive Medical, Dental, and Vision healthcare options starting from day 1.

• Flexible PTO.

• Unlimited sick leave.

• 14 company-paid holidays.

• 401K plan through Fidelity with a company match.

• Assistance with adoption and fertility.

• 16 weeks of paid parental leave.

• Company-paid life insurance.

• Company-paid disability insurance.

• Reimbursement for remote workspace expenses.

• Wellness reimbursement.

• Employee Assistance Program.

• Opportunities for career development.

• Possibilities to collaborate with colleagues globally.

• Chance to research new ophthalmic therapies that impact patients around the world.