Clinical Research Data Entry Specialist

Job Description

Job DescriptionDescription:

GENERAL SUMMARY

The Clinical Research Data Entry Specialist is responsible for the accurate, timely, and complete entry of clinical trial data into sponsor Electronic Data Capture (EDC) systems using source documentation from CRIO and other site records, ensuring protocol compliance and data integrity. This role supports efficient query resolution, successful monitoring visits, and high-quality study outcomes, while also directly contributing to site revenue by ensuring all billable visits are entered, verified, and available for invoicing within sponsor timelines, helping to reduce delays in payment and accounts receivable.

Requirements:

ESSENTIAL JOB FUNCTION/COMPETENCIES

Responsibilities include but are not limited to:

• Enter clinical trial Data from CRIO, EMR and Source Documents into sponsors EDC.
• Ensure data entry within sponsor's timelines (typically 3-5 days post vist).
• Perform quality checks and maintain data acuracy.
• Resolve Sponsor queries in collaboration with study teams.
• Reconcile CRIO eSource with EDC entries.
• Support monitoring visits and audit readiness.
• Ensure compliance with relevant regulations and guidelines governing clinical research data.
• Review source documents (e.g. medical records, laboratory reports, case report forms) to ensure data completeness and consistency.
• Track data entry progress and meet study timelines and productivity expectations.
• Participates in training related to study protocols, data systems, and compliance requirements.
• Performs other position related duties as assigned.
• Employees shall adhere to high standards of ethical conduct and will comply with and assist in complying with all applicable laws and regulations. This will include and not be limited to following the Solaris Health Code of Conduct and all Solaris Health and Affiliated Practice policies and procedures; maintaining the confidentiality of patients' protected health information in compliance with the Health Insurance Portability and Accountability Act (HIPAA); immediately reporting any suspected concerns and/or violations to a supervisor and/or the Compliance Department; and the timely completion the Annual Compliance Training.

CERTIFICATIONS, LICENSURES OR REGISTRY REQUIREMENTS

• Good Clinical Practice certification required (employees who do not hold the certification at the time of hire must obtain it within the first week of employment).

KNOWLEDGE | SKILLS | ABILITIES

• Strong attention to detail.
• Ability to manage high-volume repetitive tasks with accuracy.
• Protocol compliance and protocol specific data points (labs, AE's, mediations, procedures).
• Understand basic study flow (screening, Baseline, treatment followup.
• Strong organizational and time-management skills.
• Proficiency in Microsoft Office.
• Knowledge of Good Clinical Practice (GPC) guidelines.
• Effective written and verbal communication skills.
• Ability to identify data trends, discrepancies, and potential quality issues.
• Team-oriented mindset with a commitment to data integrity and compliance.

EDUCATION REQUIREMENTS

• High School diploma or equivalent required. Related college degree preferred.

EXPERIENCE REQUIREMENTS

• 1-3 years of experience in clinical research, healthcare data entry or related field strongly preferred.
• Familiarity with EDC systems (ie: Medidata Rave, Oracle Inform. Veeva EDC) required.

REQUIRED TRAVEL

• N/A

PHYSICAL DEMANDS

Carrying Weight Frequency

1-25 lbs. Frequent from 34% to 66%

26-50 lbs. Occasionally from 2% to 33%

Pushing/Pulling Frequency

1-25 lbs. Seldom, up to 2%

100 + lbs. Seldom, up to 2%

Lifting - Height, Weight Frequency

Floor to Chest, 1 -25 lbs. Occasional: from 2% to 33%

Floor to Chest, 26-50 lbs. Seldom: up to 2%

Floor to Waist, 1-25 lbs. Occasional: from 2% to 33%

Floor to Waist, 26-50 lbs. Seldom: up to 2%