Research Data Entry Specialist

Ironwood Cancer and Research Centers•Surprise, AZ

About The Position

The Research 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. The role 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 specialist helps maintain data integrity and supports the successful execution of clinical research studies. The position also supports quality control, query resolution, regulatory and audit readiness, and study tracking and communication.

Requirements

High school diploma or equivalent.
At least two years of data entry experience in a healthcare, medical, or clinical research environment.
Experience working with electronic health record (EHR/EMR) systems.
Ability to manage multiple priorities and deadlines.
Strong attention to detail and commitment to accuracy.
Knowledge of medical terminology.
Proficiency in Microsoft Office Suite, including 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.

Nice To Haves

Associate degree in healthcare, life sciences, business, or a related field.
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, or Florence eBinders.
Familiarity with ICH-GCP Guidelines, FDA Regulations, 21 CFR Part 11, CTCAE Adverse Event Reporting, or RECIST Tumor Response Criteria.
Current GCP training certification.
SOCRA (CCRP) or ACRP (CCRC) certification.

Responsibilities

Abstract and enter data from electronic health records, pathology reports, imaging reports, laboratory results, treatment records, and source documentation into sponsor EDC systems and internal databases.
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 clinical trial data is complete, accurate, and consistent with source documentation.
Conduct routine quality control reviews of entered data and identify and correct discrepancies.
Reconcile data among source documents, eCRFs, and internal tracking systems.
Verify protocol-required data points are documented and entered appropriately.
Support data cleaning activities and database lock preparation.
Respond to sponsor, CRO, and internal data queries in a timely manner.
Collaborate with research staff to obtain clarification and supporting source documentation.
Track and resolve open data discrepancies and action items.
Assist with preparation for sponsor monitoring visits, audits, and regulatory inspections.
Maintain organized electronic and paper study records and assist with protocol-required documentation and record retention.
Ensure compliance with HIPAA, ICH-GCP guidelines, FDA regulations, and institutional policies.
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.
Maintain strict confidentiality of patient and research-related information.
Complete required compliance, safety, and research training.
Perform additional duties as assigned by leadership.