Clinical Research Data Entry Associate (Part-time)

Description:

• Provide third-party date entry support for clinical research site(s) including EDC data entry and query resolution utilizing site electronic medical record system based on study protocol and eCRF completion guidelines.
• Preparation for this work includes study specific and site training involving site EMR access setup and vetting.
• Clinical research experience with electronic data capture (EDC) systems and familiarity with electronic medical records (EMR) required.
• Clinical research background working as a central monitor, CRA, site study coordinator, or research nurse is a must.
• Strong preference for candidates coming from CRO vs sponsor.
• Oncology experience preferred and a plus.

Clinical Data Entry Specialist

The Clinical Data Entry Specialist will be responsible for assisting Clinical Data Managers in all aspects of clinical data management tasks. Activities will include, but are not limited to: initial and double data entry, reconciliation of paper CRFs and EDC records, proper notation of data changes in the audit log, and ensuring accuracy and consistency of the data.

Key Responsibilities:

· Assists the Clinical Data Managers (CDMs) in any assigned clinical data management tasks across multiple studies

· Exhibits a high attention to detail in all tasks assigned

· Completes tasks within requested timelines and communicates task completion CDMs

· Performs review of data discrepancies and issues/assigns queries as outlined in SOPs

· Resolves assigned queries as outlined in SOPs

· May assist in user acceptance testing (UAT) of new CRFs

· Assists in regular data quality audits and follows audit documentation procedures

· Maintains proper documentation of data management activities

· Extracts, reformats, and analysis simple datasets in Excel or Access format

· Performs other duties as assigned

Required

Experience with electronic medical records and database platforms.