Clinical Research Data Entry Specialist

Posted 11 Days Ago
Be an Early Applicant
South Bend, IN, USA
In-Office
Junior
Artificial Intelligence • Healthtech • Biotech • Pharmaceutical
The Role
Enter and verify clinical trial data into EDC systems, review source documents, resolve data queries with study staff, maintain documentation and audit trails, ensure GCP/HIPAA compliance, and support monitoring, audits, and database lock timelines.
Summary Generated by Built In

Description

Clinical Research Data Entry Specialist (Onsite)

The Clinical Research Data Entry Specialist is responsible for accurately entering, reviewing, and maintaining clinical trial data in EDC systems. This role supports clinical research studies by ensuring data quality, completeness, and compliance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. This position is ideal for a detail-oriented individual with data entry or administrative experience who is interested in building a career in clinical research. 

 ObjectiveHealth is a clinical research company transforming how research is conducted at the point of care. Using our proprietary technology, we aim to:

  • Increase patient access to research trials within our communities
  • Provide physicians with enhanced care options for current patients
  • Deliver superior clinical research enrollment metrics to Pharma sponsors

All with the ultimate goal of Improving Patient Outcomes at the Point of Care. We want you to join us in doing just that.

 Key Responsibilities:

  • Enter clinical trial data into Electronic Data Capture (EDC) systems accurately and within required timelines. 
  • Review source documents and medical records to ensure complete and accurate transcription of participant data. 
  • Verify data for accuracy, completeness, and consistency prior to submission. 
  • Review, investigate, and resolve EDC data queries generated by sponsors, contract research organizations (CROs), or data management teams by comparing source documentation and collaborating with study personnel. 
  • Communicate with Clinical Research Coordinators, investigators, and other study staff to resolve missing, incomplete, or inconsistent data. 
  • Correct data discrepancies while maintaining appropriate documentation and audit trails within the EDC system. 
  • Ensure timely completion of data entry and query resolution to support study milestones and database lock. 
  • Maintain accurate study documentation related to data entry activities. 
  • Adhere to study protocols, sponsor requirements, Good Clinical Practice (GCP), HIPAA, and applicable regulatory guidelines. 
  • Assist with quality control reviews and support sponsor monitoring visits, audits, and regulatory inspections as needed. 
  • Maintain confidentiality of participant information and research data. 

Qualifications:

  • High school diploma or equivalent. 
  • 1+ years of data entry, administrative support, medical office, or related experience. 
  • Excellent attention to detail and data accuracy. 
  • Strong organizational and time management skills. 
  • Ability to manage multiple priorities and meet deadlines in a fast-paced environment. 
  • Strong written and verbal communication skills.

Requirements

This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant 

Skills Required

  • High school diploma or equivalent
  • 1+ years of data entry, administrative support, medical office, or related experience
  • Excellent attention to detail and data accuracy
  • Strong organizational and time management skills
  • Ability to manage multiple priorities and meet deadlines
  • Strong written and verbal communication skills
  • Legal authorization to work in the US (no visa sponsorship)
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The Company

What We Do

ObjectiveHealth is a Nashville-based integrated research and technology platform provider. It partners with physicians, healthcare organizations, pharmaceutical companies, and CROs to establish advanced infrastructure for clinical research programs at the point of care. By utilizing proprietary AI-driven technology and trained on-site personnel, the company aims to improve patient outcomes and expand access to innovative treatments across various therapeutic areas.

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