SUMMARY DESCRIPTION The Clinical Data Coordinator (CDC) is responsible for managing quality data entry into electronic data capture systems (EDC) from multiple protocols. The CDC will provide data management support of clinical trials from study start through maintenance and lock. The CDC maintains working knowledge of protocols and eCRF completion guidelines for assigned projects. The CDC will work with study monitors and study sites for query resolution.
*This individual will be required to come onsite periodically but will work remote most of the time.
Assist in the development and review of study-specific data management documents, including Data Management Plans, CRFs, and Case Report Form Completion Guidelines.
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.
Perform data review/cleaning for assigned protocols to ensure data completeness, quality and accuracy.
Support database closeout activities including data archiving/reporting.
Writes, reviews, and provides input to eCRF Completion Guidelines.
Executes clinical data management tasks according to the agreed upon timelines, mitigating risks as appropriate.
Performs EDC and eCRF training as needed.
Bachelor’s or Master’s degree in a scientific discipline.
Knowledge of ICH GCP and FDA regulatory requirements is required.
Strong EDC skills, e.g., Medrio, Medidata Rave, and IBM Health
Research or health care related academic or work experience preferable.
Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.
Good written and verbal communication skills.
Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook.
The compensation for this position will be between $60,000-$70,000 depending on experience.
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