Clinical Data Coordinator

Location
Pennsylvania, United States
Posted
23 Sep 2020
End of advertisement period
22 Nov 2020
Ref
JR00014577
Contract Type
Permanent
Hours
Full Time

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Job Description Summary

The Clinical Data Coordinator (DC) is responsible for providing clinical data management and operational support to the Clinical Operations team for clinical trials initiated by the Center for Cellular Immunotherapies. Specific responsibilities of the Clinical Data Coordinator are as follows:

  • Participate as a core member of the study data management team for assigned trials. 
  • Assume primary data management responsibilities for select non-interventional trials.
  • Assist in the development and review of study-specific data management documents, including Data Management Plans, CRFs, and Case Report Form Completion Guidelines (CCGs).
  • Assist with CRF development/modification and database maintenance activities.
  • Assist in the development of data management and database training materials and help facilitate Investigator/Study Team training on the Clinical Database, Case Report Forms (CRFs), and data entry requirements for assigned protocols.
  • Develop, maintain, and execute data management reports for assigned protocols.
  • Perform data review/cleaning for assigned protocols to ensure data completeness, quality and accuracy.
  • Maintain current metrics on data management activities and provide ongoing updates to project leads, PI/site team and ClinOps leadership. 
  • Support database closeout activities including data archiving/reporting. 
  • Support data management quality assurance processes including but not limited to the following:
  • Perform template and study-specific metadata review/approval.
  • Maintain CCI Field ID Library/Standardization.
  • Maintain CCI Central Data Management Forms/Document Library.
  • Perform global data review/analysis to identify data trends across studies.
  • Contribute to the development and ongoing review/maintenance of data management policies/procedures.
  • Provide daily operational support to the CCI Data Management Team.

To be successful in this role the Clinical Data Coordinator will need to maneuver within a matrixed environment and be comfortable working with various electronic database systems. The Clinical Data Coordinator is expected to have exceptional organizational skills, attention to detail, and an understanding of clinical trials and medical terminology.

Job Description

QUALIFICATIONS: 

Requirements: 

  • Bachelor’s degree with 2-3 years related experience; or combination of equivalent education/experience.
  • Clinical research background; Understanding of and experience with medical terminology.
  • Basic knowledge of electronic data capture systems preferred.
  • Experience with computer programs such as MS Word, Outlook, Excel, PowerPoint, etc.
  • Working knowledge of the drug development process and associated federal regulations and guidelines (i.e. FDA, CFR, ICH, GCP) preferred.

Preferred experience/skills: 

  • Strong organizational and problem-solving skills
  • High attention to detail
  • Demonstrated ability to manage multiple tasks simultaneously and complete work within allocated time frames
  • Excellent oral and written communication skills
  • This position is contingent upon funding.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$50,684.00 - $138,391.00

Affirmative Action Statement 

Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements 

Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

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