Note: The job is a remote job and is open to candidates in USA. Ora is a full-service ophthalmic drug and device development firm that supports clients across all phases of clinical research. The Clinical Trial Associate II assists Project Managers and study teams with clinical study conduct, site management, regulatory documentation, and study start-up, 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
- Travel Requirements less than 10%
Skills
- Bachelor's degree and a minimum of 1-year experience in clinical trials associate. Years of experience may be considered in lieu of degree
- 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
- Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work
- Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again
- Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth
- Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see
- Travel Requirements less than 10%
- Ophthalmic experience strongly preferred
Benefits
- Comprehensive healthcare options in Medical, Dental and Vision beginning day 1 for full-time employees working a minimum of 30 hours per week.
- Flexible PTO and unlimited sick time.
- 14 company-paid holidays.
- 401K plan through Fidelity with company match.
- Adoption and fertility assistance.
- 16 weeks of paid parental leave.
- Company-paid life and disability insurance.
- Remote workspace and wellness purchase reimbursement.
- Employee Assistance Program for employees and their families.
- Per diem employees are eligible for Medical and Dental coverage after 6 months of service and when working an average of 30 hours per week.
- 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.
Company Overview