Clinical Project Associate

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

📋 Description

• Establish the Trial Master File (TMF/eTMF) and manage the collection and uploading of files.

• Conduct an initial quality assessment of documents prior to their upload and filing.

• Collaborate with document specialists to ensure the TMF remains audit-ready from the beginning to the end of the study.

• Assist in verifying the qualifications of investigators and investigative sites throughout the clinical trial process.

• Distribute essential documents to investigative sites and retrieve them during the clinical trial lifecycle.

• Actively engage with Clinical Research Associates and investigative sites to address any outstanding regulatory issues.

• Examine study documents to confirm they are up-to-date, complete, and accurate.

• Manage clinical trial management systems and tracking tools effectively.

• Participate in cross-functional teams to ensure the timely delivery of project objectives.

• Undertake additional duties as assigned.

⛳️ Requirements

• A minimum of a High School Diploma or GED is required.

• At least 1 year of experience in clinical research is mandatory.

• A preference for candidates with a minimum of 3 years of clinical research experience.

• Experience in oncology clinical research is favored.

• Familiarity with Good Clinical Practices, ICH Guidelines, Federal Regulations, and Development Innovations Standard Operating Procedures is essential.

• Capability to maintain clinical trial management systems and tracking tools is necessary.

• Please note that relocation assistance and visa sponsorship are not available.

🏝️ Benefits

• A comprehensive benefits package that promotes physical, mental, and financial wellness.

• A competitive salary and compensation structure.

• Opportunities for annual bonuses or long-term incentives may be available.

• An equal opportunity employer committed to inclusivity.

• Access to resources and opportunities for personal and professional growth.

• A focus on maintaining a balanced work-life experience.