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LATE PHASE CLINICAL RESEARCH DATA ASSISTANT/DATA COORDINATOR
 
HealthCore, Inc., a health services research firm headquartered in Wilmington, DE is seeking a Clinical Research Data Assistants or Research Data Coordinators (dependent upon years of experience) to join our dynamic company. Founded in 1996, and now an independently-operating subsidiary of Anthem, Inc., HealthCore provides the health care system, biopharmaceutical industry, academia, as well as federal and state governments with "real-world" data to improve the quality, safety, and affordability of healthcare. HealthCore’s projects range from retrospective to large-scale, prospective studies in the areas of drug, vaccine, and medical device safety surveillance, risk management, pharmacoepidemiology, health outcomes, pharmacoeconomics, and comparative effectiveness research.
 
We are currently seeking an experienced Clinical Data Coordinator to join our team in either our Wilmington, DE or Watertown, MA locations. The primary role of the Clinical Data Coordinator is to provide daily assurance of the quality of data collected within the Electronic Data Capture (EDC) system as well as supporting the design of the electronic Case Report Forms (eCRFs) for HealthCore’s late phase research studies. These type of studies include but are not limited to Pragmatic Clinical Trials (PCTs), Post-Authorization Safety Studies (PASS), and Disease or Product Registries.
 
Responsibilities include:
  • Works collaboratively with Clinical Programmers, CRA, Statistical Programmers, Biostatisticians and others to meet project deliverables and timelines for routine to basic clinical data acquisition, quality checking and reporting.
  • Assists in the preparation of CRF/eCRF data collection through the regulatory approval process.
  • Contributes to the development of timelines for key clinical data management deliverables in coordination with the various area functional leads.
  • Ensures completeness, correctness and consistency of clinical data and data structure.
  • Generates and utilizes reports to track study progress and ensure timeliness and quality expectations are met.
  • Assists field clinical staff in collecting data to meet the protocol requirements in a timely manner.
  • Identifies, tracks, and resolves basic queries.
  • Assists in the implementation of clinical data management process with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery.
  • Monitors and reports on vendor performance to ensure timelines and data quality standards are met.
  • Develops drafts of Data Management materials such as CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, and electronic data transfer agreements.
  • Contributes insight and content to clinical data management Processes, Guidelines and Standard Operating Procedures (SOPs).
  • Effectively communicates with Data Management teammates as well as cross-functional team members and possesses good problem solving skills.
  • Sound understanding of pertinent regulations such as ICH-GCP guidelines and 21CFR11.
LATE PHASE CLINICAL RESEARCH DATA ASSISTANT
 
We are currently seeking an experienced Clinical Research Data Assistant to join our team in either our Wilmington, DE or Watertown, MA locations. The primary role of the Clinical Data Coordinator is to provide daily assurance of the quality of data collected within the Electronic Data Capture (EDC) system as well as supporting the design of the electronic Case Report Forms (eCRFs) for HealthCore’s late phase research studies. These type of studies include but are not limited to Pragmatic Clinical Trials (PCTs), Post-Authorization Safety Studies (PASS), and Disease or Product Registries.
 
Responsibilities include:
  • Works collaboratively with Data Coordinators and Data Managers to meet project deliverables and timelines for routine to basic clinical data acquisition, quality checking and reporting.
  • Assists in the preparation of CRF/eCRF data collection through the regulatory approval process.
  • Ensures completeness, correctness and consistency of clinical data and data structure.
  • Identifies, tracks, and resolves basic queries.
  • Performs manual edit checks within the EDC system as needed.
  • Generates daily/weekly/monthly automated reports to assist DM team with project management.
  • Provides user access for Electronic Data Capture (EDC) system.
  • Assists in the implementation of clinical data management process with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery.
  • Reviews and contributes to Data Management materials such as CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, and electronic data transfer agreements.
  • Handle all DM document management and files reports within each individual project folder.
  • Contributes insight to clinical data management Processes, Guidelines and Standard Operating Procedures (SOPs).
  • Sound understanding of pertinent regulations such as ICH-GCP guidelines and 21CFR11.
 
Qualifications:

• Bachelor’s Degree in Epidemiology, Sociology, Psychology, Public Health, Natural Sciences or related field.
1-3 years of experience in research data collection and data collection coordination efforts required. Experience with survey or chart-abstracted research and knowledge of medical chart components desired. Data management experience a plus.
• Proven attention to detail.
• Demonstrated ability to multi-task and meet deadlines.
• Ability to work in a fast-paced and rapidly-changing environment.
• Evidence of self-sufficiency and independence in data collection responsibilities.
• Minimal travel may be required. Experience with Electronic Data Capture (EDC) systems preferred.

In addition to a dynamic work environment, HealthCore offers a competitive salary and an outstanding benefits program, including a 401(k) plan; health, dental, and vision insurance; discounted fitness club membership; life, AD&D, short and long-term disability insurance coverage; tuition assistance, and paid parking. HealthCore’s headquarters are located in Wilmington, DE, midway between New York City and Washington, DC, with additional offices in Atlanta, GA; Andover, MA; and Alexandria, VA. As an independently operating subsidiary of Anthem, Inc., HealthCore offers the resources of the nation’s leading health benefits company in a small company environment.

To learn more about us or apply for a position, please visit www.healthcore.com
An Equal Opportunity Employer/Disability/Veteran

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