Clinical Research Associate: Onsite Monitoring & Impact

Parexel; Boston (MA); Presencial; USD 65.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Descripción de la vacante

Parexel is seeking a Clinical Research Associate (CRA) to join our Boston team with a minimum of 12 months of onsite monitoring experience. You will manage sites from qualification through closeout, ensuring study quality, patient safety, regulatory compliance, and accurate data.

The role emphasizes strong site relationships and proactive issue resolution. You will conduct monitoring visits, support enrollment, and ensure adherence to GCP and protocol requirements.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Site relationship mgmt

Problem solving

Communication skills

Independent work

Client focus

Prioritization

Quality minded

Educación

Bachelor's degree or equivalent in a health-related field

Knowledge of Good Clinical Practice (GCP)

Herramientas

CTMS

EDMS

Microsoft Office

Excel

Word

Descripción del empleo

Parexel is seeking a Clinical Research Associate (CRA) to join our Boston team with a minimum of 12 months of onsite monitoring experience. You will manage sites from qualification through closeout, ensuring study quality, patient safety, regulatory compliance, and accurate data.

The role emphasizes strong site relationships and proactive issue resolution. You will conduct monitoring visits, support enrollment, and ensure adherence to GCP and protocol requirements.