[Hiring] Clinical Project Associate @Sarah Cannon Research Institute

Role Description

As the Clinical Project Associate, you are responsible for ensuring the Trial Master File (TMF) is set-up and maintained in “audit ready” condition; and conduct critical documentation collection and review throughout the lifecycle of the study, in accordance with Good Clinical Practices, ICH Guidelines, Federal Regulations and Development Innovations SOPs. You will maintain clinical trial management systems and tracking tools, actively participating in cross-functional teams to ensure delivery of project deliverables.

This position is remote based in the US; relocation assistance and visa sponsorship are not available.

• You will set-up, document collection/upload of files to the TMF/eTMF.
• You will perform initial quality review of documents prior to upload/filing in the TMF/eTMF.
• You will partner with document specialist to maintain the Trial Master File (TMF) in “audit ready” condition from study start to completion.
• You will assist with confirming the qualifications of investigators and investigative sites throughout the conduct of the clinical trial.
• You perform critical document distribution to and collection from the investigative sites throughout the lifecycle of the clinical trial. Proactively liaise with Clinical Research Associate and investigative site to resolve outstanding regulatory issues.
• You review study documents to ensure they are current, complete and accurate.
• Other duties as assigned.

Qualifications

• Minimum High School Diploma or GED.
• At least 1 year of clinical research experience required; at least 3 years of clinical research experience preferred.
• Oncology clinical research experience preferred.

Benefits

• Comprehensive benefits to support physical, mental, and financial well-being.
• Competitive compensation package determined by performance, experience and skills, equity, regular job market evaluations, and geographical markets.
• Other compensation, such as an annual bonus or long-term incentive opportunities may be offered.