Biospecimen & Clinical Data Coordinator (Cancer Trials)

CCR CTCA Clinical Research, Inc.; Goodyear (AZ); On-site; USD 60,000 - 95,000; Full time

Job summary

City of Hope is seeking a Biospecimen Coordinator to support clinical trials with rigorous data management and specimen handling. You will help establish data standards, assist with study start-up, protocol review, CRF and database reviews, and define dataset specifications.

You will develop data correction processes, resolve discrepancies, perform data validation with source documents, and support study closeout with regulatory submissions; enter data in CTMS and generate enrollment reports;

Qualifications

• Bachelor’s degree in a life science, computer science or related field or equivalent.
• Minimum of 1 year in Clinical Data Management, industry, or research experience.
• Knowledge of medical/oncology terminology and data handling practices.

Responsibilities

• Build and maintain data standards for clinical trials and biospecimens.
• Assist with study start-up: protocol review, CRFs, and database review.
• Define dataset specifications, data transfer specs, and handling plans.
• Develop data correction processes, discrepancy resolution, and validation with source documents.
• Support studies from preparation to closeout, including regulatory submissions.
• Ensure FDA/ICH guidelines compliance and CTMS data entry with enrollment reports.
• Process and ship biospecimen samples per protocol and IATA requirements.

Skills

Clinical Data Mgmt

Oncology terminology

MS Access

Excel

EDC systems

Education

Bachelor’s degree (life science, computer science or related)

Tools

Inform

TrialManager

Medidata

RedCap

Job description

City of Hope is seeking a Biospecimen Coordinator to support clinical trials with rigorous data management and specimen handling. You will help establish data standards, assist with study start-up, protocol review, CRF and database reviews, and define dataset specifications.

You will develop data correction processes, resolve discrepancies, perform data validation with source documents, and support study closeout with regulatory submissions; enter data in CTMS and generate enrollment reports;