Source Document Specialist

Sarah Cannon Research Institute • Nashville, TN

1d

About The Position

The Source Document Specialist supports the Study Coordinator with daily study activities and helps ensure work follows company standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable ICH regulations and guidelines. The role supports industry trial data deadlines and assists with clinical trial documentation and study administration.

The specialist obtains source documentation for enrolled patients, helps complete case report forms and resolve queries as needed, and assists in obtaining medical records, including research charts. The role creates and maintains tracking spreadsheets for medical record and research chart accountability, maintains and archives study administrative files, and coordinates with Tennessee Oncology medical records departments and Iron Mountain to locate and account for records. The specialist meets regularly with the project manager and assesses adherence to applicable SOPs, GCP, and ICH requirements.

Requirements

• Associate degree.
• At least 2 years of experience working in a health care organization; oncology experience preferred.
• Knowledge of scientific, medical, and regulatory terminology.
• Knowledge of GCP and Good Manufacturing Practice (GMP).
• Detail-oriented.
• Excellent written and oral English skills.

Nice To Haves

• Bachelor’s degree preferred.
• Oncology experience preferred.
• Healthcare experience, clinical trials support, or pharmaceutical industry experience preferred.

Responsibilities

• Support the Study Coordinator with daily activities and trial data deadlines.
• Obtain source documentation for patients enrolled in clinical trials.
• Assist with case report form completion and query resolution as needed.
• Assist the Study Coordinator in obtaining medical records, including research charts.
• Create and maintain spreadsheets tracking medical record and research chart accountability.
• Maintain and archive study administrative files.
• Work with Tennessee Oncology medical records departments to ensure record accountability.
• Work with Iron Mountain to locate archived records.
• Meet regularly with the project manager.
• Assess adherence to Sarah Cannon SOPs, GCP, and applicable ICH regulations and guidelines.

Benefits

• Comprehensive benefits supporting physical, mental, and financial well-being.
• Competitive compensation package.
• An annual bonus or long-term incentive opportunities may be offered.

What This Job Offers

• Job Type: Full-time
• Education Level: Associate degree