Clinical Data Coordinator
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Posted Job Title
Clinical Data Coordinator
Job Profile Title
Data Analyst C
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.
- 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.
- 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
Department / School
Perelman School of Medicine
$50,684.00 - $138,391.00
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