Clinical Research Associate - Onsite Trial Monitor

Parexel; Frankfort (KY); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is hiring a Clinical Research Associate (CRA) with at least 1 year of onsite monitoring experience to join our team in the United States. You will manage clinical sites from site identification through closeout, ensuring study quality, patient safety, regulatory compliance, and accurate data.

You will conduct onsite monitoring, build site relationships, address issues, and support enrollment and study delivery while leveraging Parexel technology and training to advance your career in

Qualifications

• At least 12 months of direct onsite monitoring experience as a Clinical Research Associate.
• Bachelor's degree or equivalent in biological science, pharmacy, or another health-related discipline.
• Knowledge of Good Clinical Practice, applicable regulatory requirements, and clinical trial processes.
• Experience using a Clinical Trial Management System, an Electronic Document Management System, and Microsoft Office applications, including Excel and Word.
• Strong interpersonal, written, verbal, organizational, and problem-solving skills.
• Oncology, Ophthalmology, CAR-T, and/or MASH clinical trial monitoring experience preferred.

Responsibilities

• Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) at assigned clinical sites, and prepare timely visit and contact reports.
• Manage site quality and delivery from site identification through closeout.
• Serve as the primary point of contact for assigned clinical sites, addressing questions and resolving issues to support successful study execution.
• Oversee study integrity and build effective relationships with investigators and site staff.
• Review trial performance at designated sites and help safeguard the rights, safety, and well-being of study participants in accordance with the protocol.
• Develop patient recruitment strategies with clinical sites to support enrollment timelines.
• Ensure compliance with approved standard operating procedures, study protocols and amendments, Good Clinical Practice, and applicable regulatory requirements.
• Evaluate the quality and integrity of reported data, site performance, and investigational product accountability.
• Monitor the completeness and quality of regulatory documentation and perform site document verification.

Skills

Site relationship management

Independent with urgency

Client-focused & adaptable

Multitasking & timeline management

Attention to quality & detail

Clear communication in matrix teams

Education

Bachelor's degree in biological sciences/health-related discipline

Tools

Clinical Trial Management System

Electronic Document Management System

Microsoft Excel

Microsoft Word

Job description

Parexel is hiring a Clinical Research Associate (CRA) with at least 1 year of onsite monitoring experience to join our team in the United States. You will manage clinical sites from site identification through closeout, ensuring study quality, patient safety, regulatory compliance, and accurate data.

You will conduct onsite monitoring, build site relationships, address issues, and support enrollment and study delivery while leveraging Parexel technology and training to advance your career in