Clinical Research Associate

About the Company
We are a specialized, growing Contract Research Organization (CRO) supporting innovative clinical research programs across a focused portfolio of therapeutic areas. As a smaller CRO, we offer our team the opportunity to work closely with clients, investigators, and internal leadership while taking meaningful ownership of study execution.
Our work is highly collaborative and hands-on. We value CRAs who are clinically knowledgeable, proactive, detail-oriented, and comfortable working in an environment where every team member has a meaningful impact on the success of our studies and clients.
Position Overview
We are seeking an experienced Clinical Research Associate (CRA) to support clinical trials across oncology, ophthalmology, or pulmonary hypertension.
The ideal candidate brings strong site-management and monitoring experience, sound knowledge of ICH-GCP and applicable regulations, and a genuine interest in working within a specialized CRO environment. Experience in one or more of our core therapeutic areas is strongly preferred.
This position provides the opportunity to work across multiple studies and phases of clinical development while developing strong relationships with study teams, investigators, and clients.
Key Responsibilities
Conduct qualification, initiation, routine monitoring, and close-out visits in accordance with study protocols, SOPs, ICH-GCP, and applicable regulations.
Perform on-site and remote monitoring activities, including source data review, source data verification, investigational product accountability, and review of essential documents.
Ensure study sites are appropriately trained and understand protocol requirements and study procedures.
Identify, document, and escalate protocol deviations, compliance concerns, data issues, and other risks.
Review clinical data and query activity to support data quality and study integrity.
Maintain strong, proactive communication with investigators, coordinators, and study teams.
Track site performance, enrollment, data quality, outstanding action items, and study timelines.
Support development and maintenance of study-specific tools, monitoring plans, visit reports, and follow-up communications.
Collaborate closely with Project Managers, Clinical Operations, Medical, Data Management, and other functional teams.
Participate in investigator meetings, site training, study team meetings, and client meetings as needed.
Provide regular updates regarding site status, risks, issues, and opportunities to the study team.
Contribute to process improvement initiatives as the CRO continues to grow.
Maintain a high level of quality, professionalism, and ownership across all assigned studies.
Therapeutic Area Experience
Experience in one or more of the following areas is highly desirable:
Oncology
Solid tumors and/or hematologic malignancies
Oncology clinical trial monitoring
RECIST or other tumor response assessments
Safety monitoring and adverse event reporting
Ophthalmology
Ophthalmic clinical trials
Familiarity with ophthalmic assessments, imaging, or specialized endpoints
Experience working with ophthalmology investigators and specialized clinical sites
Pulmonary Hypertension
Pulmonary arterial hypertension (PAH) and/or related pulmonary hypertension studies
Familiarity with specialized cardiovascular/pulmonary assessments and endpoints
Experience working with specialized academic or community pulmonary hypertension centers
Qualifications
Bachelor's degree in a health science, life science, nursing, or related field; equivalent clinical research experience may be considered.
3+ years of clinical research monitoring experience in a CRO, pharmaceutical, biotechnology, or related environment.
Demonstrated experience conducting monitoring visits from site qualification through close-out.
Strong working knowledge of ICH-GCP, FDA regulations, and applicable clinical research requirements.
Experience with clinical trial management systems and electronic data capture platforms.
Strong written and verbal communication skills.
Excellent organizational skills and attention to detail.
Ability to manage multiple priorities and work independently.
Willingness and ability to travel to clinical research sites as required.
Oncology, ophthalmology, or pulmonary hypertension experience strongly preferred.

Work arrangement
Yes