Clinical Research Associate II

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

Preferred

Ophthalmic experience is strongly preferred

Multilingual communication is a plus

Benefits

Comprehensive healthcare options in Medical, Dental and Vision beginning day 1 for eligible full-time employees.

Flexible PTO and unlimited sick time, in addition to 14 company paid holidays.

401K plan through Fidelity with company match.

Adoption and fertility assistance.

16 weeks paid Parental Leave.

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.

Full-time employees working a minimum of 30 hours per week are eligible for the benefits described. Per diem employees are eligible for Medical and Dental coverage after 6 months of service if they work an average of 30 hours per week.

Full-service ophthalmic drug and device development firm.

Andover, Massachusetts, USA

http://www.oraclinical.com/

Growth Stage

Leadership Team

Buffie Kerstetter

Director, Preclinical Partnerships

Recent News

Business Wire

Bridging Clinical Practice and Drug Development, Ora Appoints Dr. John Trein as Therapeutic Lead, Posterior

2026-08-18

Pharmafile

New web series explores path from ophthalmic research to patient access

2026-04-30

Ora Unveils Breakthrough Research in Ophthalmic Clinical Trials, New Blind Canvas Project Stories at ARVO 2026

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Qualifications

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

Travel Requirements up to 75%

Ophthalmic experience is strongly preferred

Multilingual communication is a plus

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.

Required skills

Clinical Site Monitoring, ICH-GCP Compliance, Clinical Research Protocols, Source Data Verification, Federal Research Regulations, Excel, CTMS, Electronic Data Capture (EDC), Ophthalmic Clinical Research

Preferred skills

Ophthalmic experience is strongly preferred, Multilingual communication is a plus

Experience

2+ years