Source Document Specialist

McKesson Corporation; Nashville (TN); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Total Rewards package

Job summary

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, seeks a Source Document Specialist to support the Study Coordinator in daily trial activities. You will ensure compliance with SOPs, GCP, and ICH guidelines while managing source documentation and research charts.

Ideal candidates have an associate degree and at least 2 years in a health care setting (oncology preferred), with detail-oriented and strong English communication skills.

Qualifications

• Associate degree required; bachelor degree preferred.
• At least 2 years’ experience in a health care organization; oncology preferred.
• Knowledge of scientific, medical, and regulatory terms.
• Knowledge of GCP and GMP.
• Detail-oriented with strong written and oral English skills.
• Healthcare experience, clinical trials support, or pharmaceutical industry experience preferred.

Responsibilities

• Support Study Coordinator to meet industry trial data deadlines.
• Obtain source documentation for patients enrolled in trials.
• Assist with case report form completion when needed.
• Assist with query resolution as needed.
• Assist to obtain medical records including research charts.
• Create and maintain spreadsheet for medical record and research chart accountability.
• Maintain and archive study administrative files.
• Collaborate with Tennessee Oncology medical record departments for accountability of records.
• Coordinate with Iron Mountain to locate archived records.
• Meet with project manager on a regular basis.
• Assess adherence to Sarah Cannon SOPs, GCP and ICH regulations and guidelines.

Skills

Attention to detail

English proficiency

Healthcare experience

Education

Associate degree

Bachelor preferred

Tools

GCP knowledge

GMP knowledge

Job description

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.

As the Source Document Specialist you will provide support to the Study Coordinator on a daily basis, ensure all activities are conducted according to company SOPs, and all applicable GCP and ICH regulations and guidelines.

• You will support the Study Coordinator to meet industry trial data deadlines.
• You will obtain source documentation for patients enrolled into clinical trial.
• You will assist the Study Coordinator with case report form completion if needed.
• You will assist the Study Coordinator with query resolution if needed.
• You will assist the Study Coordinator to obtain medical record including research chart.
• You will create and maintain spreadsheet for medical record and research chart accountability.
• You will maintain and archive study administrative files.
• You will work closely with Tennessee Oncology medical record departments to assure accountability of records.
• You will work closely with Iron Mountain to locate archived records.
• You will meet with project manager on a regular basis.
• You will assess adherence to Sarah Cannon SOPS, Good Clinical Practice (GCP) and ICH regulations and guidelines.

What you should have for this role:

• An Associate Degree; Bachelor Degree preferred
• At least 2 years of experience working in health care organization - oncology preferred
• Knowledge of scientific, medical, and regulatory terms
• Knowledge of GCP and Good Manufacturing Practice (GMP)
• Detail-oriented
• Excellent English written and oral skills.
• Healthcare experience, Clinical trials support, or pharmaceutical industry 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.

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.

McKesson job postings are posted on our career site: careers.mckesson.com.

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.