Research Data Entry Specialist

Position Summary:

The Data Entry Specialist accurately abstracts, reviews, and enters patient and study data into electronic case report forms (eCRFs), sponsor electronic data capture (EDC) systems, and internal clinical research databases. This position supports oncology clinical trials by ensuring research data is complete, timely, accurate, and audit-ready in accordance with study protocols, sponsor requirements, Good Clinical Practice (GCP), and regulatory guidelines.

Working closely with Clinical Research Coordinators and Research Nurses, the Data Entry Specialist plays a critical role in maintaining data integrity and supporting the successful execution of clinical research studies.

Essential Duties and Responsibilities:

Data Management

• Abstract and enter data from electronic health records (EHR), pathology reports, imaging reports, laboratory results, treatment records, and source documentation into sponsor EDC systems and internal databases.
• Accurately document study visits, treatment administration, adverse events, concomitant medications, laboratory values, tumor assessments, and follow-up data according to protocol requirements.
• Complete data entry within sponsor-required and department-established timelines.
• Ensure all clinical trial data is complete, accurate, and consistent with source documentation.

Quality Assurance

• Conduct routine quality control reviews of entered data to identify and correct discrepancies.
• Reconcile data between source documents, electronic case report forms (eCRFs), and internal tracking systems.
• Verify protocol-required data points are appropriately documented and entered.
• Support data cleaning activities and database lock preparation.

Query Resolution

• Respond to sponsor, CRO, and internal data queries in a timely manner.
• Collaborate with research staff to obtain clarification and supporting source documentation when needed.
• Track and resolve open data discrepancies and action items.

Regulatory and Audit Support

• Assist in preparing for sponsor monitoring visits, audits, and regulatory inspections.
• Maintain organized electronic and paper study records.
• Ensure compliance with HIPAA, ICH-GCP guidelines, FDA regulations, and institutional policies.
• Assist with protocol-required documentation and record retention activities.

Reporting and Communication

• Maintain study enrollment, follow-up, and data management tracking logs.
• Communicate data status, outstanding queries, and approaching deadlines to the research team.
• Participate in departmental meetings, training activities, and process improvement initiatives.

Additional Responsibilities

• Maintain strict confidentiality of patient and research-related information.
• Complete required compliance, safety, and research training.
• Perform additional duties as assigned by leadership.

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Minimum Qualifications

Required Education

• High school diploma or equivalent required.
• Associate degree in healthcare, life sciences, business, or related field preferred.

Required Experience

• Minimum of two (2) years of data entry experience in a healthcare, medical, or clinical research environment.
• Experience working with electronic health record (EHR/EMR) systems.
• Demonstrated ability to manage multiple priorities and deadlines.

Knowledge, Skills, and Abilities

• Strong attention to detail and commitment to accuracy.
• Knowledge of medical terminology.
• Proficiency in Microsoft Office Suite (Excel, Word, Outlook, and Teams).
• Strong organizational, analytical, and time-management skills.
• Effective written and verbal communication skills.
• Ability to work independently and collaboratively within a multidisciplinary team.
• Typing proficiency of at least 45 words per minute.
• Ability to maintain strict confidentiality and professionalism.

Preferred Qualifications

• Experience supporting oncology clinical trials.
• Experience with industry-sponsored, cooperative group, or investigator-initiated research studies.

Experience using:

• Medidata Rave
• Oracle InForm
• Veeva EDC
• OnCore CTMS
• Florence eBinders

Familiarity with:

• ICH-GCP Guidelines
• FDA Regulations
• 21 CFR Part 11
• CTCAE Adverse Event Reporting
• RECIST Tumor Response Criteria

Current GCP training certification.

SOCRA (CCRP) or ACRP (CCRC) certification preferred.

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