Remote Clinical Research Associate II (West US)

Parexel; City of Albany (NY); A distancia; USD 70.000 - 95.000; Jornada completa

Descripción de la vacante

Parexel is seeking a Clinical Research Associate to act as the primary site contact and site manager across all trial phases. You will oversee allocated sites and ensure compliance with ICH-GCP, sponsor SOPs, and regulatory requirements.

You will develop strong site relationships, coordinate monitoring activities both remotely and on-site, and support document collection, visit reporting, and site performance improvements to maintain trial integrity and patient safety.

Formación

• A minimum of 2 years of direct site monitoring experience in bio/pharma/CRO.
• Experience with ICH-GCPs and regulatory documentation is required.
• Strong understanding of protocol conduct and site audits.

Responsabilidades

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates and provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure data quality and patient safety.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses, and resolves site performance, quality or compliance problems and escalates as appropriate.
• Maintains information and documentation in CTMS, eTMF and other systems as appropriate.

Conocimientos

Site management

Monitoring

GCP/ICH knowledge

Data interpretation

Communication skills

IT proficiency

Independent work

Multicultural teamwork

Educación

Bachelor's degree

Descripción del empleo

Parexel is seeking a Clinical Research Associate to act as the primary site contact and site manager across all trial phases. You will oversee allocated sites and ensure compliance with ICH-GCP, sponsor SOPs, and regulatory requirements.

You will develop strong site relationships, coordinate monitoring activities both remotely and on-site, and support document collection, visit reporting, and site performance improvements to maintain trial integrity and patient safety.