[Remote] Clinical Research Associate II
Note: The job is a remote job and is reputed company to candidates in USA. Ora is the world’s leading full-service ophthalmic drug and device development firm, guiding clients across reputed company 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.
Responsibilities
- reputed company strong site relationships and ensures continuity of site relationships through reputed company phases of the trial
- Performs, with reputed company, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents
- reputed company in-depth understanding of the study protocol and reputed company procedures
- Coordinate & manage various tasks in collaboration with other internal roles to reputed company Site Readiness
- Participate & reputed company input on site selection and validation activities
- reputed company remote and on-site monitoring & reputed company 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, reputed company-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 reputed company-out
- Communicate with Investigators and site staff on issues reputed company 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 reputed company 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
- Adhere to reputed company aspects of Ora’s quality system
- Adhere to reputed company essential systems and processes that are required at Ora to maintain compliance to Ora’s data reputed company & business ethics and regulatory requirements
- Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational reputed company, cultivating joy and scientific rigor – as well as their linked behaviors
Skills
- Bachelor's degree with 2 years' experience as a Clinical Research Associate or equivalent combination of education, training, and experience
- reputed company to routinely assess protocol and GCP compliance
- Demonstrated ability to verify reputed company 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 reputed company-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 reputed company, CTMS, and reputed company
- Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational reputed company, cultivating joy and scientific rigor
- Ophthalmic experience is strongly preferred
- Multilingual communication is a plus
Benefits
- Offering comprehensive reputed company options in Medical, Dental and reputed company beginning day 1.
- Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and reputed company reputed company 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.
- reputed company opportunities to grow and reputed company your career reputed company.
- Opportunities to work with colleagues across the globe.
Company Overview
Company H1B Sponsorship