Quality Assurance Associate (Pharmaceuticals)

Sarah Cannon Research Institute; Tennessee; Remote; USD 65,000 - 90,000; Full time

Job summary

Sarah Cannon Research Institute (SCRI) is seeking a Clinical Project Associate to ensure TMF setup and audit-ready maintenance throughout studies, in line with GCP, ICH, FDA regulations, and SCRI SOPs. You will support TMF/eTMF processes and track deliverables with cross-functional teams.

Remote-based in the United States, the role requires basic clinical research experience; oncology trials are preferred. Relocation or visa sponsorship are not available.

Qualifications

• At least 1 year of clinical research experience required; at least 3 years of clinical research experience preferred.
• Oncology clinical research experience preferred.

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 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.
• Proactively liaise with Clinical Research Associate and investigative sites to resolve outstanding regulatory issues.
• Review study documents to ensure they are current, complete and accurate.

Education

High School Diploma or GED

Job description

Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.

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

• 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. to learn more about our research offerings.

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. 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.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.