Clinical Trials Data Assistant Senior

Department: MED-Cancer Center
Salary/Grade: EXS/5

Job Summary:

Serves as a resource to staff regarding data entry, maintenance, and results. Coordinates incoming data for accuracy and integrity, assists with complex data preparation, analyzes data, and creates reports. Ensures associated administrative tasks such as documentation, editing of codebooks and manuals, etc. are completed.

• The Data Assistant Sr. is responsible for the compilation of all data for clinical trials managed by the CTO. Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress and final reports. Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data

Specific Responsibilities:

Strategic Planning

• Identifies and assesses customer data needs.
• Assists in identifying organization area's data integration and related records solutions.
• Collaborates on a variety of data management projects including variable definitions, storage, etc.
  • Obtain required training for all electronic data capture systems.
  • Obtains applicable protocol specific training.
  • Abstract all required patient data from medical record sources for entry into case report forms (paper and/or electronic).
  • Follow timelines stated in SOP (CO-SM-312) and individual sponsor contracts, for data entry and query resolution.
  • Seek out data by contacting other hospitals and physician offices to obtain medical records as needed.
  • Main contact for monitors/CRO's for data query resolution.
  • Responsible for the long term follow-up with patients who are no longer receiving active treatment which may involve direct contact with patients, their families and/or referring physicians.
  • Responds to sponsor/CRO data concerns and escalates issues to management as appropriate.

Administration

• Ensures that all data is obtained and verified for subsequent analysis.
• Provides updates and summaries regarding statistics.
• Provides administrative support to organizational area.
  • Attend mandatory scheduled meetings
  • Increase knowledge of all disease specific oncology studies to ensure efficient data abstraction and resolution of queries.
  • Assesses protocol compliance and communicates directly with the study coordinator and PI when compliance issues are identified.
  • Assist with all internal audit requests.
  • Gives input on CTO policies and procedures with regards to data entry monitoring.

Development

• Writes queries and reports and creates necessary analysis.
• Schedule and participate in all monitor visits for assigned studies.
  • Facilitate EMR access for monitors.
  • Resolve issues noted in follow-up letter within 3 weeks
  • Assists with any sponsor audit requests.
• Runs and distributes standard scheduled reports.
• Maintains and updates report inventory.

Supervises

• Assists in mentoring training entry level data assistants.

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications:

• A high school diploma or equivalent is required.
• 4 years' data entry or similar experience is required.

Minimum Competencies: (Skills, knowledge, and abilities.)

• Ability to understand complex pathology data and cancer treatment regimens and their toxicities.
• Ability to establish and maintain effective working relationships with patients, physicians, nurses, technicians and co-workers.
• Excellent verbal and written communication
• Medical terminology
• Critical thinking
• Self-learner

Preferred Qualifications:

• Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in health sciences, social sciences, advertising/marketing, or related; OR appropriate combination of education and experience.
• Experience in data management in a health field, exposure to cancer clinical trials.
• Computer literate in basic software, internet use, and cancer-related databases.
• At least 1 year of work experience in a customer service oriented position
• 1-2 years' experience in cancer research
• 1-2 years' experience in Clinical Trials.

Preferred Competencies: (Skills, knowledge, and abilities)

• Prior administrative or public responsibility desirable.
• Experience in data management in a health field
• Exposure to cancer clinical trials
• Assertiveness
• Critical Thinker
• Independent Learner
• Computer Proficiency
• Compliance
• Communication - Oral and Written
• Medical Terminology
• Quality/Compliance

Target hiring range for this position will be between $48,000-$65,500 per year. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data.

Benefits:
At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.

Work-Life and Wellness:
Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles.
We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.

Professional Growth & Development:
Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.

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