Clinical Trial Associate I

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

📋 Description

• Assist Project Managers and study teams in the execution of ophthalmic clinical studies.

• Provide support for feasibility oversight, site contracts, budgets, regulatory document collection, and scheduling of follow-up patient visits.

• Ensure that study documentation, communication, training, and data collection align with protocols, SOPs, regulations, and guidelines.

• Draft and review documents and templates related to the study.

• Engage in study initiation, maintenance, and closeout activities, including participation in Investigator Meetings.

• Collect and evaluate site regulatory documents.

• Prepare essential document packages necessary for investigational product release and site approval.

• Create regulatory submission packages for IRB/IEC and continuity/closeout submissions.

• Assemble and distribute regulatory binders.

• Order and ship study supplies to clinical sites.

• Create, obtain approval for, and submit site payments to the Accounting department.

• Assist Clinical Research Associates during monitoring visits and organize missing documents in the eTMF and site binder.

• Support project management activities through meeting agendas/minutes, communications, CTMS, and study trackers.

• Aid in the preparation of study metric reports and site status updates.

• Establish and maintain the Trial Master File/eTMF and file-sharing platforms.

• Address Quality Control findings resulting from Trial Master File audits.

• Participate in Study Operations planning, risk assessments, and pre-study meetings.

• Promote process improvement, SOP compliance, and departmental training.

• Assist with preparations for audits by Sponsors, IRB/IEC, and the FDA.

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

⛳️ Requirements

• Bachelor’s Degree with at least 1 year of research experience, including relevant coursework; years of experience may substitute for education.

• A minimum of 1 year of clinical trial experience is highly preferred.

• Experience in ophthalmic research.

• Ability to thrive in a semi-virtual, cross-functional team environment.

• Strong analytical and problem-solving skills.

• Consistent sense of urgency and keen attention to detail.

• Familiarity with GCP/ICH regulations.

• Experience in maintaining electronic trial master files.

• Excellent verbal and written communication abilities.

• Outstanding organizational and time management skills to juggle multiple trials, critical tasks, and process improvement initiatives.

• Multilingual communication skills are a plus.

• Capability to set goals, create structure, and maintain a focused and collaborative approach.

• A growth mindset characterized by authenticity, transparency, resilience, empathy, and curiosity.

• Proficient in practicing clear and direct communication, providing feedback, and resolving conflicts.

• Commitment to the values and mission of Ora.

🏝️ Benefits

• An inclusive and supportive work environment.

• A fulfilling work-life balance.

• Equal employment opportunity and fair, equitable compensation.

• Up to 10% travel opportunity/requirement.