The Senior Data Assistant serves as a key resource for data management and analysis related to clinical trials. Responsibilities include data integrity, compliance, reporting, and collaboration with internal and external stakeholders. The role requires both administrative and technical expertise, particularly in oncology and clinical trials data.
Primary Responsibilities:
Strategic Planning:
- Assess customer data needs and recommend solutions for data integration and records management.
- Collaborate on data management projects, including variable definitions and storage methods.
- Obtain and maintain required training for electronic data capture systems and protocol-specific requirements.
Data Collection and Management:
- Abstract patient data from medical records for case report forms (paper/electronic).
- Ensure timely data entry and query resolution per SOPs and sponsor contracts.
- Serve as a liaison for monitors and CROs regarding data query resolution.
- Maintain long-term follow-up for patients no longer receiving active treatment, which may involve direct contact with patients, families, and referring physicians.
Analysis and Reporting:
- Compile and verify data for analysis.
- Create progress and final reports.
- Run scheduled reports and maintain report inventory.
Compliance and Coordination:
- Assess protocol compliance and collaborate with study coordinators and PIs to address issues.
- Assist with internal audits and sponsor audit requests.
- Schedule and participate in monitor visits and resolve follow-up issues.
Minimum Qualifications:
- High school diploma or equivalent.
- At least 4 years of experience in data entry or a related field.
- Proficiency in medical terminology and understanding of oncology data and treatment regimens.
- Strong critical thinking and communication skills.
Preferred Qualifications:
- Bachelor’s degree in health sciences, social sciences, or related fields (or equivalent education and experience).
- 1-2 years of experience in cancer research or clinical trials.
- Proficiency with cancer-related databases and data management software.
- Customer service experience.
Core Competencies:
- Assertiveness and ability to handle challenging situations.
- Ability to work independently and exercise critical thinking.
- High proficiency in communication (oral and written).
- Strong organizational skills and attention to detail.
Work Environment and Physical Requirements:
- Office-based with occasional travel to other locations.
- Regular use of a computer with frequent data entry.
- Light lifting (up to 10 pounds) and occasional mobility within the office environment.