Medical Data Coordinator

Overview

Topography is seeking a full time medical data coordinator to facilitate EDC entries from electronic source documents.  The ideal candidate has previous experience as a clinical research coordinator and has performed data entry in a variety of electronic data capture (EDC) systems. Additionally, the candidate  will show strong technical aptitude, the ability to work autonomously while maintaining open lines of communication in a remote work environment, and show experience with adverse events, concomitant medications, and protocol adherence in the clinical research industry.

KEY RESPONSIBILITIES

1.Ensure data entry is entered into case report forms (CRFs) and completed within the contracted study timelines while reviewing and QCing electronic source documents

2.Review discrepancies in entered data, make appropriate corrections or request clarifications as needed

3.Perform data verification routines in accordance with our company’s policies and procedures

4.Interact with other staff members and sponsors on clinical data queries

5.Understand and comply with the Health Insurance Portability and Accountability Act (HIPAA) to support data redactions and uploads to case report forms (CRFs) and other study systems by removing patient identifiers from patient clinic reports and/or as needed in any patient records.

6.Support the study coordinators with timely recruitment and screening of qualified study participants for ongoing research studies

7.Understand and comply with all regulations, policies, and guidelines applicable to clinical research, including our SOPs

8.Ensure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation

9.Participate in Quality Control activities including routine QC checks during and following study visits

10.Any other duties assigned by manager 

MINIMUM QUALIFICATIONS

High school diploma or equivalent

1+ years in or within an EMR (vendor agnostic)

1+ years data entry experience in EDC Systems

1+ years experience in electronic source platforms

1+ years of clinical research experience, clinical research assistant or coordinator preferred