Clinical Trials 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

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.