Clinical Research Associate: Onsite Monitoring Pro

Parexel; Montpelier (VT); Sur place; USD 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Résumé du poste

Parexel is seeking a Clinical Research Associate (CRA) in Montpelier, VT to support onsite monitoring activities and maintain strong site relationships, ensuring patient safety and data integrity. You will conduct visits, manage site delivery, and collaborate with cross-functional teams to advance clinical trials while adhering to GCP, SOPs, and regulatory requirements.

You will partner with investigators, coordinate recruitment strategies with sites, and contribute to study timelines.

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.

Responsabilités

• 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.

Connaissances

Site relationship management

Problem-solving

Communication

Independent work

Attention to quality

Matrix collaboration

Formation

Bachelor’s degree in biological science, pharmacy, or health-related discipline

Outils

Clinical Trial Management System

Electronic Document Management System

Microsoft Office (Excel, Word)

Description du poste

Parexel is seeking a Clinical Research Associate (CRA) in Montpelier, VT to support onsite monitoring activities and maintain strong site relationships, ensuring patient safety and data integrity. You will conduct visits, manage site delivery, and collaborate with cross-functional teams to advance clinical trials while adhering to GCP, SOPs, and regulatory requirements.

You will partner with investigators, coordinate recruitment strategies with sites, and contribute to study timelines.