[Remote] Clinical Research Associate II

Note: The job is a remote job and is open to candidates in USA. Ora 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 II is responsible for developing strong site relationships and ensuring compliance with assigned protocols while monitoring site activities.ResponsibilitiesDevelop strong site relationships and ensures continuity of site relationships through all phases of the trialPerforms, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documentsGain in-depth understanding of the study protocol and related proceduresCoordinate & manage various tasks in collaboration with other internal roles to achieve Site ReadinessParticipate & provide input on site selection and validation activitiesPerform remote and on-site monitoring & oversight activities using various tools to ensure:Data generated at site are complete, accurate and unbiasedSubjects’ right, safety and well-being are protectedConducts 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 mannerCollect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-outCommunicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performanceIdentify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line managerManage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelinesSupports audit/inspection activities as neededAdhere to all aspects of Ora’s quality systemAdhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirementsClear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviorsSkillsBachelor's degree with 2 years' experience as a Clinical Research Associate or equivalent combination of education, training, and experienceCapacity to routinely assess protocol and GCP complianceDemonstrated ability to verify source data to reported dataStrong attention to detail to review the completeness of the investigator site fileKnowledge to reconcile and return/destroy test articles while conducting initiation, interim, and close-out visitsKnowledge 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 protocolProficiency with Excel, CTMS, and EDCClear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigorOphthalmic experience is strongly preferredMultilingual communication is a plusBenefitsOffering 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.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.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.Continued opportunities to grow and develop your career journey.Opportunities to work with colleagues across the globe.Company OverviewOra is an ophthalmic clinical research and product development firm. It was founded in 1985, and is headquartered in Andover, Massachusetts, USA, with a workforce of 201-500 employees. Its website is http://www.oraclinical.com/.Company H1B SponsorshipOra has a track record of offering H1B sponsorships, with 1 in 2025, 2 in 2024, 1 in 2022, 1 in 2021, 1 in 2020. Please note that this does not guarantee sponsorship for this specific role.