In-House Clinical Research Associate – Contract

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the daily execution of a Phase 3 clinical trial, covering study start-up, execution, and closure.

• Act as the main point of contact for designated clinical sites and CRO field CRAs/monitors.

• Liaise with sites and CRO partners to gather updates, address issues, and ensure adherence to study timelines.

• Facilitate site initiation, continuous site management, and finalization activities.

• Identify, document, monitor, and follow up on site-related issues.

• Oversee CRO monitoring activities.

• Review monitoring visit reports and address action items as well as unresolved findings.

• Track monitoring deliverables and escalate concerns to the Associate Director of Clinical Operations.

• Assist with inspection readiness and audit preparations.

• Maintain study tracking tools that encompass site activation, enrollment, visits, essential documents, TMF status, and vendor reconciliation.

• Generate study status reports and relevant metrics.

• Collect, review, and monitor regulatory documents from sites.

• Organize documents within the TMF/eTMF and conduct TMF quality control.

• Aid in TMF audits and the study closure process.

• Coordinate internal, investigator, and study-related meetings.

• Prepare meeting materials, document minutes, and maintain action item logs.

• Relay study updates to internal stakeholders.

• Provide support for various ad hoc Clinical Operations projects.

⛳️ Requirements

• A. or B.S. degree is required.

• A minimum of 1-2 years of experience in supporting clinical trials within a sponsor or CRO setting.

• Familiarity with clinical trial operations and ICH GCP guidelines.

• Experience using TMF/eTMF systems (Veeva Vault preferred).

• Proficient in the Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

• Excellent organizational skills and meticulous attention to detail.

• Capability to manage multiple priorities and meet deadlines.

• Strong interpersonal skills and an ability to work collaboratively with cross-functional teams and external partners.

• Willingness to travel as business needs require (less than 5% expected).

• Ability to perform sedentary work, including occasional lifting of up to 10 pounds.

• Capability to engage in repetitive wrist, hand, finger, typing, and speaking activities.

🏝️ Benefits

• Equal employment opportunities.

• Anticipated travel of less than 5% (with travel support/participation).