Remote In-House Clinical Research Associate I

Worldwide Clinical Trials; United States; Remote; USD 85,000 - 120,000; Full time

Job summary

Worldwide Clinical Trials is seeking an Inhouse Clinical Research Associate to support study delivery and compliance with GCP and regulatory requirements. You will liaise with trial managers, sites, and cross‑functional teams to drive quality study execution and timely milestones.

The role emphasizes site management, documentation control, data quality, and proactive operational support across global sites, with a remote work setup for suitable candidates.

Qualifications

• Bachelor's degree in a medical, biological, physical, health, pharmacy or related science field preferred or equivalent education/experience.
• Clinical research experience in roles such as Study Coordinator or Clinical Trial Assistant.
• Knowledge of GCP, FDA/EU regulations, ICH Guidelines and SOPs.

Responsibilities

• Support site start‑up activities, including feasibility questionnaire coordination and essential document management.
• Coordinate distribution and tracking of study materials to investigative sites and ensure documentation is maintained.
• Review site documentation for quality and TMF maintenance and reconciliation.
• Conduct remote monitoring activities and support pre‑study, initiation, interim and closeout visits.
• Maintain regular communication with investigative sites and provide operational support.
• Review electronic case report forms and study data for completeness and compliance.
• Assist sites with data management queries, vendor requests, recruitment activities, and eligibility tracking.
• Generate study reports, maintain trackers, and provide updates for effective oversight.
• Support site personnel changes, training documents, regulatory collection, and vendor access management.

Skills

Planning & organization

Communication skills

English proficiency

Clinical research knowledge

GCP knowledge

Regulatory knowledge (FDA/EU)

EDC/eCRF familiarity

Team collaboration

Education

Four-year degree in science/related field

Tools

EDC

eCRF

IVRS

Job description

Worldwide Clinical Trials is seeking an Inhouse Clinical Research Associate to support study delivery and compliance with GCP and regulatory requirements. You will liaise with trial managers, sites, and cross‑functional teams to drive quality study execution and timely milestones.

The role emphasizes site management, documentation control, data quality, and proactive operational support across global sites, with a remote work setup for suitable candidates.