This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Clinical Research Associate in the United States.
This role is a key field-based clinical position supporting the execution and oversight of ophthalmic clinical trials across multiple study sites. You will act as the primary point of contact for assigned sites, ensuring compliance with study protocols, ICH-GCP guidelines, and regulatory requirements throughout all phases of clinical research. Working closely with cross-functional teams, you will help ensure data quality, patient safety, and study integrity from start-up through close-out. The role requires strong relationship-building skills, as you will develop and maintain trusted partnerships with investigators and site staff. You will also contribute to site selection, monitoring activities, and operational issue resolution in a highly regulated research environment. This position offers meaningful impact in advancing innovative ophthalmic therapies that improve patient outcomes globally.
Accountabilities:- Manage and oversee clinical trial site activities to ensure compliance with ICH-GCP, protocols, SOPs, and applicable regulatory requirements across all study phases.
- Build and maintain strong site relationships, ensuring consistent communication and effective collaboration throughout the clinical trial lifecycle.
- Conduct remote and on-site monitoring visits, including initiation, interim, evaluation, and close-out visits, while documenting findings accurately and timely.
- Review and verify source data, ensuring accuracy, completeness, and alignment with reported clinical trial data.
- Support site selection and qualification activities by assessing site capabilities and readiness for clinical research participation.
- Monitor study progress, including recruitment, retention, protocol adherence, and regulatory documentation compliance.
- Identify, investigate, and resolve site performance or compliance issues in collaboration with clinical leadership.
- Maintain accurate study documentation within CTMS, eTMF, and other clinical systems in accordance with timelines and quality standards.
- Support audit and inspection readiness activities and ensure proper handling of investigational materials during study phases.
Requirements:
- Bachelor’s degree with at least 3 years of experience as a Clinical Research Associate, or equivalent combination of education and relevant experience.
- Strong understanding of ICH-GCP guidelines, clinical trial regulations, and site monitoring practices.
- Proven ability to conduct monitoring visits and assess site compliance, data integrity, and patient safety.
- Experience verifying source data and ensuring consistency with clinical trial records.
- Ability to evaluate investigative site capabilities and support site qualification and selection.
- Strong attention to detail with experience managing regulatory documentation and investigator site files.
- Proficiency with clinical research systems such as CTMS and EDC, as well as Excel.
- Strong communication and interpersonal skills for working with investigators, site staff, and internal teams.
- Ability to manage multiple priorities and travel up to 75% as required.
- Ophthalmology clinical research experience is strongly preferred.
Benefits:
- Comprehensive medical, dental, and vision insurance starting on day one.
- Competitive compensation with 401(k) retirement plan and company match.
- Flexible PTO policy, unlimited sick time, and 14 paid company holidays.
- Paid parental leave (up to 16 weeks) and family support including adoption and fertility assistance.
- Life and disability insurance fully paid by the company.
- Remote work and wellness reimbursement program to support home office and personal well-being.
- Employee assistance program providing confidential support services.
- Career development opportunities and global collaboration exposure.
- Opportunity to contribute to impactful ophthalmic research improving patient outcomes worldwide.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
#LI-CL1