Clinical Project Associate

McKesson; Tennessee; Hybrid; USD 65,000 - 90,000; Full time

Job summary

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, is seeking a Clinical Project Associate. The role ensures the Trial Master File (TMF) is set up and maintained in audit-ready condition, with review of documents throughout the study lifecycle and collaboration with cross-functional teams.

Responsibilities include TMF setup, quality review, and site qualification assistance. Remote-based in the US; relocation assistance and visa sponsorship are not available.

Qualifications

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

Responsibilities

• Set up and maintain the TMF/eTMF files.
• Perform initial quality review of documents prior to upload.
• Collaborate with document specialists to keep TMF audit-ready from start to finish.
• Assist with confirming the qualifications of investigators and investigative sites.
• Distribute and collect study documents with sites throughout the trial lifecycle.
• Review study documents to ensure current, complete, and accurate records.

Skills

Documentation management

Cross-functional teamwork

Quality review

Education

High School Diploma or GED

Tools

TMF/eTMF systems

Job description

About Sarah Cannon Research Institute

It’s More Than a Career, It’s a Mission. 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. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. 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 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; relocation assistance and visa sponsorship are not available.

Responsibilities

Duties include and are not limited to:

• 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 & Compensation

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.

Equal Opportunity & Inclusion

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.