Sr Clinical Research Associate (Sr CRA) - Ophthalmology-Remote

MSD • Chicago, IL

4d • $129,000 - $203,100 • Remote

About The Position

The Sr Clinical Research Associate (Sr CRA) in Ophthalmology is responsible for the performance and compliance of assigned protocols and sites within a country. This role ensures adherence to ICH/GCP, country regulations, company policies, and quality standards, including adverse event reporting. The Sr CRA acts as the primary site contact and manager throughout all study phases, taking responsibility for allocated sites and actively developing new clinical research sites. They also participate in internal meetings as a Subject Matter Expert (SME) for monitoring processes and systems.

Requirements

• Associate’s degree, certificate, or equivalent in a scientific/healthcare discipline with at least 7 years of relevant experience in the healthcare field, including at least 4 years of direct site management (monitoring) experience in bio/pharma/CRO.
• OR Bachelor’s degree (or above) with at least 4 years of direct site management (monitoring) experience in a bio/pharma/CRO.
• 5 years of Ophthalmology experience required.
• Fluent in Local Languages and English (verbal and written).
• Excellent communication skills, including the ability to understand and present technical information effectively.
• Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Demonstrated ability to mentor/lead.
• Hands-on knowledge of Good Documentation Practices.
• Proven skills in Site Management including independent management of site performance and patient recruitment.
• Demonstrated high level of monitoring skill with independent professional judgment.
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications.
• Ability to understand and analyze data/metrics and act appropriately, also in a virtual environment.
• Experience with conducting site motivational visits designed to boost site enrollment.
• Capable of managing complex issues, works in a solution-oriented manner.
• Performs root cause analysis and implements preventative and corrective action.
• Effective time management, organizational, and interpersonal skills, conflict management, problem-solving skills.
• Able to work highly independently across multiple protocols, sites, and therapy areas.
• High sense of accountability/urgency.
• Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
• Works effectively in a matrix multicultural environment.
• Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus.
• Works with high quality and compliance mind-set.
• Positive mindset, growth mindset, capable of working independently and being self-driven.
• Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.
• Current driver’s license required.
• Must reside in Texas, Illinois, Indiana, Ohio, or Tennessee.

Nice To Haves

• Retina experience preferred.

Responsibilities

• Develops strong site relationships and ensures continuity through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates & provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure data accuracy, completeness, and subject safety.
• Conducts site visits (validation, initiation, monitoring, close-out) and records clear, comprehensive, and accurate reports.
• Collects, reviews, and monitors required regulatory documentation for study start-up, maintenance, and close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, deviations, documentation, audits/inspections, and site performance.
• Identifies, assesses, and resolves site performance, quality, or compliance problems, escalating as appropriate.
• Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal, and regional operations, HQ functional areas, and externally with vendors, IRB/IECs, and Regulatory Authorities.
• Manages and maintains information and documentation in CTMS, eTMF, and other systems.
• Contributes to CRA team knowledge by acting as a process SME, sharing best practices, making recommendations for continuous improvement, and providing training.
• Supports and/or leads audit/inspection activities as needed.
• Contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
• Mentors/buddies junior CRAs on process/study requirements and performs co-monitoring visits.
• Could perform Quality control visits if delegated and trained.

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days
• Annual bonus
• Long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree