Ora · 1 day ago
Clinical Research Associate I
United States
Full-time
Remote
Entry Level
1+ years expOra is the world’s leading full-service ophthalmic drug and device development firm, guiding clients across all phases of clinical research. The Clinical Research Associate I will develop strong clinical site relationships and ensure compliance of study conduct by monitoring site activities according to regulations and policies.
BiotechnologyConsultingHealth CareLegalPharmaceutical
Responsibilities
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
Qualification
Required
Bachelor's degree with 1 years' experience in the clinical research field or equivalent combination of education, training and experience
Capacity to routinely assess protocol and GCP compliance
Demonstrated ability to verify source data to reported data
Strong attention to detail in order to review completeness of the investigator site file
Knowledge to reconcile and return/destroy test article 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 a comprehension of a clinical research protocol as well as understand the importance of following the protocol
Proficiency with Excel, CTMS and EDC
Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor
Preferred
Ophthalmic experience strongly preferred
Multilingual communication is a plus
Benefits
Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays.
Competitive salaries along with a 401K plan through Fidelity with company match.
Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave.
Offering peace of mind to help you and your family feel secure.
We'll reimburse you to support your remote workspace and wellness purchases.
No matter what issues you're facing, New Directions is here to help you and your family.
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
Ora
Ora is an ophthalmic clinical research and product development firm.
201-500 employees
H1B Sponsorship
Ora has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (2)
2022 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Paul Colvin
Chief Operating Officer
Aron Shapiro
Sr. Vice President, Asset Development & Partnering
Recent News
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