Clinical Project Associate

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

📋 Description

• Establish the Trial Master File (TMF/eTMF) and gather and upload necessary documents.

• Conduct initial quality assessments of documents prior to TMF/eTMF submission.

• Collaborate with document specialists to ensure the TMF remains audit-ready throughout the study.

• Assist in verifying the qualifications of investigators and investigative sites.

• Distribute and gather essential documents from investigative sites during the clinical trial.

• Coordinate with Clinical Research Associates and investigative sites to address unresolved regulatory concerns.

• Examine study documents for relevance, completeness, and precision.

• Engage in cross-functional teams to support project objectives.

• Oversee clinical trial management systems and tracking tools.

• Carry out documentation collection and review throughout the study lifecycle in compliance with relevant guidelines and regulations.

• Execute additional responsibilities as assigned.

⛳️ Requirements

• Minimum of a High School Diploma or GED.

• A minimum of 1 year of clinical research experience is required.

• Experience in oncology clinical research is preferred.

• At least 3 years of clinical research experience is preferred.

• Familiarity with Good Clinical Practices, ICH Guidelines, Federal Regulations, and Development Innovations SOPs.

• Must be located in the US.

• Ability to work with clinical trial management systems and tracking tools is necessary.

🏝️ Benefits

• Comprehensive benefits that promote physical, mental, and financial health.

• Annual bonus or long-term incentive opportunities may be available.

• Relocation assistance is not provided.

• Visa sponsorship is not available.