Clinical Trial Associate II at Ora in Remote - US

Job description

• Ora’s Clinical Trial Associate II (CTA II) assists Project Managers and study teams in clinical study conduct for clinical ophthalmic projects. They support the oversight feasibility including but not limited to, working with sites to generate contracts and budgets, collecting regulatory documents, and may be involved in scheduling follow up patient visits of all clinical sites and ensures compliance with (GCP) protocol along with overall clinical objectives. Ora’s CTA II’s participate in all phases of clinical studies including start up, study maintenance, and close-out activities.

Responsibilities

• Ensure study documentation, communication, training and data collection is aligned with study protocol adherence, and all applicable SOPs, regulations and guidelines
• Lead the development of assigned study-related documents (e.g., informed consent, source documents, study logs, etc.).
• Participate in all phases of clinical trial site management from study start-up, through study conduct and completing closeout activities.
• Collect and review site regulatory documents for accuracy and completion (1572, Financial Disclosure documents, CLIA waivers, etc.)
• Prepare essential documents package to support investigational product release for study and site approval as well as applicable study and site continuity report submissions and close-out submissions.
• Create regulatory packages for IRB/IEC study and site submission, as well as applicable continuity report, and close-out submissions.
• May assemble and distribute regulatory binders to clinical sites and provide monitors with Investigator Site File tracker in support of monitoring visits
• Support project management activities including providing meeting minutes/agendas and weekly newsletter to the clinical team, as well as maintaining the clinical study tracking systems.
• Assist project managers in preparing study reports and collecting site status updates and study metrics
• Set-up and maintain the Trial Master File/electronic Trial Master File, and applicable filesharing platforms (i.e. Box.com, department server files) for clinical projects
• QC Trial Master File (for clinical projects where individual is not setting up and maintaining the file)
• Participate in Study Operations planning, Risk Assessment discussions, and Pre-Study Meetings.
• Provide support to Clinical Operations for implementing process improvement actions, performing bi-annual reviews of applicable SOPs, and conducting departmental training sessions
• Assist with Sponsor/IRB/IEC audit preparations and participate in response to audit findings.
• Adhere to all aspects of Ora’s quality system.
• Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements.
• Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.
• Responsibilities may differ from the above based on the specific needs of the business.

Requirements

• Bachelor's degree and a minimum of 1-year experience in clinical trials associate. Years of experience may be considered in lieu of degree
• Ophthalmic experience strongly preferred
• Ability to work both alone as well as in a semi-virtual, cross-functional team environment.
• Ability to apply analytical and problem-solving skills; ability to act with a consistent sense of urgency and acute attention to detail.
• Knowledge of GCP/ICH regulations.
• Experience maintaining electronic trial master files
• Excellent verbal and written communication skills.
• Exceptional organizational and time management skills in order to manage multiple trials, critical tasks and departmental process improvement efforts.
• Ability to remotely problem-solve with members of site staff.

Skills

Required

• Knowledge of GCP/ICH regulations

Preferred

• Ophthalmic experience

Benefits

• Well Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays.
• Financial: Competitive salaries along with a 401K plan through Fidelity with company match.
• Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave.
• Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure.
• Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases.
• Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family.
• Career Development Opportunities: Continued opportunities to grow and develop your career journey.
• Global Team: Opportunities to work with colleagues across the globe.
• Impact: A chance to research new ophthalmic therapies that will impact patients across the globe.
• Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.