Clinical Trial Associate

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

📋 Description

• Provide administrative assistance to the project team.

• Aid the Project Manager in communicating with the project team and various sites.

• Support site pre-identification and feasibility assessments.

• Gather initial essential documents from the sites.

• Assist with the implementation of study activities, including preparation of regulatory and essential documents as well as IRB/IEC submissions.

• Develop study-specific documents and materials.

• Maintain organizational charts for the study and project-specific tracking systems.

• Conduct background checks for Principal Investigators.

• Create Investigator Site Files and tailor study templates as needed.

• Upload and assign training materials in the Learning Management System, and keep the Project Team Training Matrix updated.

• Procure and distribute study materials and supplies to sites and Clinical Research Associates (CRAs).

• Assist with Annual/Continuing Review IRB submissions across North America.

• Help organize meetings and prepare minutes and action items.

• Request translations when necessary.

• File, review, classify, name, and maintain documents in the electronic Trial Master File, adhering to the eTMF plan.

• Support periodic quality control reconciliation of the TMF and assist with project close-out.

• Establish and structure project email accounts and aid in email organization.

• Maintain in-depth knowledge of Veeva Vault for eTMF and offer user support for the system.

• Perform additional duties as assigned.

⛳️ Requirements

• Associate degree or equivalent experience is required.

• At least two years of clinical research experience is necessary.

• Strong written and verbal communication abilities, with a good command of English.

• Excellent interpersonal and communication skills are essential.

• Familiarity with ICH, GCP, FDA, MHRA, EMA regulations, and local guidelines is important.

• Capability to thrive in a matrixed team environment.

• Commitment to quality and meticulous attention to detail.

• Ability to prioritize and handle multiple tasks effectively.

• Proficiency in computer systems, applications, and operating systems is required.

• Must be able to endure extended periods of sitting at a desk and working on a computer.

🏝️ Benefits

• PTO.

• Comprehensive benefits package.