Note: The job is a remote job and is open to candidates in USA. Ora is a global ophthalmic drug and device development firm that supports clients across all phases of clinical research. The Clinical Research Associate II develops site relationships and monitors clinical study activities to ensure protocol, ICH-GCP, regulatory, and sponsor compliance while protecting subject safety and data integrity.
Responsibilities
- Responsibilities may differ slightly from the above based on specific needs of the business
- Develop strong site relationships and ensures continuity of site relationships through all phases of the trial
- Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents
- Gain in-depth understanding of the study protocol and related procedures
- Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness
- Participate & provide input on site selection and validation activities
- Perform remote and on-site monitoring & oversight activities using various tools to ensure:
- Data generated at site are complete, accurate and unbiased
- Subjects’ right, safety and well-being are protected
- Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner
- Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out
- Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
- Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager
- Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines
- Supports audit/inspection activities as needed
- Travel Requirements up to 75%
- 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
Skills
- Bachelor's degree with 2 years' experience as a Clinical Research Associate or equivalent combination of education, training, and experience. Years of experience may be considered in lieu of education
- Capacity to routinely assess protocol and GCP compliance
- Demonstrated ability to verify source data to reported data
- Strong attention to detail to review the completeness of the investigator site file. Knowledge to reconcile and return/destroy test articles while conducting initiation, interim, and close-out visits
- Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs)
- Ability to read and demonstrate comprehension of a clinical research protocol as well as understand the importance of following the protocol
- Proficiency with Excel, CTMS, and EDC
- 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
- Ophthalmic experience is strongly preferred
- Multilingual communication is a plus
Benefits
- Comprehensive healthcare options in Medical, Dental and Vision beginning day 1 for eligible employees.
- Flexible PTO and unlimited sick time for eligible employees.
- 14 company paid holidays.
- 401K plan through Fidelity with company match.
- Adoption and fertility assistance for eligible employees.
- 16 weeks paid Parental Leave for eligible employees.
- Company-paid life and disability insurance.
- Remote workspace and wellness purchase reimbursement.
- Employee Assistance Program through New Directions for employees and their families.
- 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.
- Benefit eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Per diem workforce is eligible for Medical and Dental coverage after 6 months of service and an average of 30 hours per week.
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