[Remote] Senior Clinical Research Associate

Note: The job is a remote job and is open to candidates in USA. Ora is a leading full-service ophthalmic drug and device development firm, dedicated to advancing clinical research in ophthalmology. The Senior Clinical Research Associate (Sr. CRA) is responsible for developing strong clinical site relationships and ensuring compliance with study protocols while monitoring site activities throughout all phases of clinical trials.

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

Skills

• Bachelor's degree with 3 years' experience as a Clinical Research Associate or equivalent combination of education, training and experience
• Ophthalmic experience is strongly preferred
• Capacity to routinely assess protocol and GCP compliance
• Ability to understand how to properly assess an investigative site's capabilities to conduct clinical research
• Demonstrated ability to verify source data to reported data
• Ability to monitor and report on the progress of the trial from start-up to completion
• Knowledge of how to select and qualify an investigative site
• 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
• Advanced 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
• Multilingual communication is a plus
• 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

Benefits

• Offering 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 Overview

Company H1B Sponsorship