Clinical Project Associate - Remote US

About the role

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.

Responsibilities

• Set-up, document collection/upload of files to the TMF/eTMF
• Perform initial quality review of documents prior to upload/filing in the TMF/eTMF
• Partner with document specialist to maintain the Trial Master File (TMF) in “audit ready” condition from study start to completion
• Assist with confirming the qualifications of investigators and investigative sites throughout the conduct of the clinical trial
• 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
• Review study documents to ensure they are current, complete and accurate
• Other duties as assigned

Requirements

• 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

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade.

SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S.

Benefits

We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves.

As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.