Clinical Trial Associate II

Ora

2d•Hybrid

About The Position

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.

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.

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.

Benefits

Comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
Flexible PTO & Unlimited Sick Time
14 company paid holidays
401K plan through Fidelity with company match.
Adoption and fertility assistance
16 weeks paid Parental Leave.
Company Paid Life & Disability Insurance
Remote & Wellness Reimbursement
Employee Assistance Program
Continued opportunities to grow and develop your career journey.
Opportunities to work with colleagues across the globe.
A chance to research new ophthalmic therapies that will impact patients across the globe.