Clinical Research Associate: Site Monitoring Expert

Parexel; Annapolis (MD); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health, Vision & Dental 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 seeking a Clinical Research Associate (CRA) to join our team in the United States. The role focuses on onsite monitoring, site management, and patient safety across therapeutic areas.

You will manage site relationships, ensure regulatory compliance, and support enrollment timelines while advancing quality data and study integrity. Strong communication and problem-solving are essential.

Qualifications

• 12 months of direct onsite monitoring experience as a CRA
• Bachelor's degree or equivalent in biological science, pharmacy, or health-related discipline
• Knowledge of GCP, regulatory requirements, and clinical trial processes
• Experience using CTMS, EDMS, and MS Office applications including Excel and Word
• Strong interpersonal, written, verbal, organizational, and problem-solving skills
• Oncology, Ophthalmology, CAR-T, and/or MASH trial monitoring experience preferred

Responsibilities

• Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) with timely visit and contact reports
• Manage site quality and delivery from site identification through closeout
• Serve as the primary contact for assigned clinical sites and resolve issues to support study execution
• Oversee study integrity and build relationships with investigators and site staff
• Review trial performance at designated sites and safeguard participant rights and safety
• Develop patient recruitment strategies with clinical sites to support enrollment timelines
• Ensure compliance with SOPs, study protocols, amendments, GCP, and regulatory requirements
• Evaluate data quality and site performance; accountability of investigational product
• Verify completeness of regulatory documentation and site file verifications

Skills

Site relationship management

Problem-solving

Communication skills

Independent with urgency

Education

Bachelor's degree in biological science/pharmacy/health-related discipline

Tools

CTMS

EDMS

MS Office (Excel/Word)

Job description

Parexel is seeking a Clinical Research Associate (CRA) to join our team in the United States. The role focuses on onsite monitoring, site management, and patient safety across therapeutic areas.

You will manage site relationships, ensure regulatory compliance, and support enrollment timelines while advancing quality data and study integrity. Strong communication and problem-solving are essential.