Northwestern University · 1 day ago
Clinical Trials Data Assistant Senior
Northwestern University is seeking a Clinical Trials Data Assistant Senior to serve as a resource for data entry, maintenance, and results within the Cancer Center. The role involves coordinating and analyzing clinical trial data, ensuring accuracy and integrity, and providing consultation on data management and methodological issues.
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Responsibilities
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
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
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
Assists in mentoring training entry level data assistants
Performs other duties as assigned
Qualification
Required
A high school diploma or equivalent is required
4 Years' Data Entry Or Similar Experience Is Required
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
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
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
Benefits
Meaningful, competitive, high-quality health care plans
Retirement benefits
Tuition discounts
Comprehensive programs and services to help you and your family navigate life’s challenges and opportunities
Flexible work arrangements
Programs to help you locate and pay for quality, affordable childcare and senior/adult care
Employee career development
Tools and resources for continuing your formal education
Company
Northwestern University
Northwestern University is a private research and teaching university that offers academic programs across various fields of study. It is a sub-organization of Northwestern Athletics.
H1B Sponsorship
Northwestern University has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (325)
2024 (308)
2023 (280)
2022 (282)
2021 (184)
2020 (155)
Funding
Current Stage
Late StageTotal Funding
$98.02MKey Investors
National Peanut BoardAdvanced Research Projects Agency for HealthGRAMMY Museum
2024-10-30Grant
2024-10-04Grant· $34M
2023-11-28Grant· $0.02M
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