Postúlate en Kit Empleo: kitempleo.com.co/empleo/1aqojx

Job Description:

We are seeking a highly skilled and experienced Clinical Research Assistant to join our growing clinical research team. The adecuado candidate will have strong experience in clinical research operations, electronic data capture (EDC) entry using CRIO, and quality control review processes. Candidates must possess exceptional attention to detail, accuracy in documentation, and a strong understanding of clinical research workflows and compliance standards.

Key Responsibilities:

EDC Data Entry: Accurately enter clinical trial data into Electronic Data Capture (EDC) systems using CRIO in accordance with study protocols and sponsor requirements.

Quality Control (QC): Perform quality control reviews of clinical research data, source documents, and study records to ensure completeness, consistency, and compliance.

Data Verification: Review patient charts, source documents, lab reports, and study documentation for accurate transcription into the EDC system.

Protocol Compliance: Ensure all data entry and documentation activities comply with study protocols, GCP guidelines, sponsor requirements, and regulatory standards.

Issue Resolution: Identify discrepancies, missing data, and inconsistencies and coordinate with research staff to resolve queries promptly.

Documentation Management: Maintain organized and accurate clinical trial documentation, including regulatory files and study-related records.

Collaboration: Work closely with Clinical Research Coordinators (CRCs), investigators, sponsors,



and other research staff to support ongoing studies and ensure data integrity.

Qualifications:

Experience: Minimum of 5 years of experience in clinical research operations, clinical data entry, and/or quality control.

CRIO Experience: Hands-on experience using CRIO as a CTMS and/or EDC platform is required.

Clinical Research Knowledge: Strong understanding of clinical trial workflows, source documentation, GCP guidelines, and regulatory compliance.

Attention to Detail: Excellent attention to detail with the ability to maintain high levels of accuracy in data entry and quality review tasks.

Communication Skills: Strong English verbal and written communication skills.

Tech-Savvy: Proficient in EDC systems, CTMS platforms, Microsoft Office, and other clinical research technologies.

Preferred Qualifications:

Experience working in a Clinical Research Organization (CRO), research site, or with study sponsors.

Experience with data query resolution and sponsor audits is a plus.

CRC training or certification is an advantage.

Job Type:
Full-time

Benefits:

Work from home

Schedule:

8-hour shift

Texas, USA business hours (8 AM to 5 PM CST)

Supplemental Pay:

Discretionary bonus

Experience:

Clinical Research: 5 years (Required)

Using CRIO as CTMS/EDC: 1 year (Required)

Language:

English (Required)

Job Type: Full-time

Experience:

- Clinical Research: 5 years (Required)
- using CRIO as CTMS: 1 year (Required)

Language:

- English (Required)

Work Location: Remote

Postúlate en Kit Empleo: kitempleo.com.co/empleo/1aqojx

📌 [Remote] Clinical Research Assistant (Texas, USA business hours) (Colombia)
🏢 GoAdvisors
📍 Colombia