Clinical Research Data Entry Associate (Part-time)

Planet Pharma; Fair Lawn (NJ); Sur place; USD 52 000 - 70 000; Plein temps

Résumé du poste

Planet Pharma is seeking a Clinical Data Entry Specialist to support Clinical Data Managers with initial and double data entry, reconciliation of paper CRFs and EDC records, and proper audit log notation. The role requires experience with electronic medical records and EDC systems, with a background in clinical research such as a CRA, site study coordinator, or research nurse.

Strong attention to detail and timely task completion are essential, along with data extraction and simple analysis in

Qualifications

• Experience with electronic medical records and database platforms.
• Clinical data management experience in EDC/EMR environments.
• Strong attention to detail in data tasks and audits.
• Ability to work across multiple studies and timelines.

Responsabilités

• Assist CDMs with data management tasks across studies.
• Perform initial and double data entry and reconcile CRFs/EDC records.
• Review data discrepancies and raise or resolve queries per SOPs.
• Assist in user acceptance testing (UAT) of new CRFs.
• Maintain documentation of data management activities.

Connaissances

Attention to detail

Data entry accuracy

Communication skills

Outils

EDC systems

Electronic Medical Records (EMR)

Description du poste

Description:

• Provide third-party date entry support for clinical research site(s) includingEDCdata 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 andEDCrecords, 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.