Clinical Trials Data Entry Specialist (Onsite)

ObjectiveHealth; South Bend (IN); On-site; USD 40,000 - 55,000; Full time

Job summary

ObjectiveHealth is seeking a Clinical Research Data Entry Specialist (Onsite) to accurately enter and review clinical trial data in EDC systems. The role requires meticulous data transcription from source documents, with a focus on data quality, completeness, and regulatory compliance.

The ideal candidate has 1+ years of data entry or related administrative experience, strong organizational skills, and the ability to manage multiple priorities in a fast-paced environment.

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.

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, 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.

Skills

Data entry

Attention to detail

Organizational skills

Time management

Communication skills

Education

High school diploma or equivalent

Job description

ObjectiveHealth is seeking a Clinical Research Data Entry Specialist (Onsite) to accurately enter and review clinical trial data in EDC systems. The role requires meticulous data transcription from source documents, with a focus on data quality, completeness, and regulatory compliance.

The ideal candidate has 1+ years of data entry or related administrative experience, strong organizational skills, and the ability to manage multiple priorities in a fast-paced environment.