Project Description

Client Instruction

Job Title: Clinical Trial Data Entry & Research Documentation Assistant

Objective:
Accurately input, validate, and maintain clinical trial patient data for a Phase II drug efficacy study. Work includes strict compliance with Good Clinical Practice (GCP) guidelines, ensuring accuracy, completeness, and confidentiality of all trial-related information. The final deliverables must be suitable for submission to regulatory bodies (FDA/EMA) and for use in peer-reviewed publications.

Scope of Work:

1. Enter patient case report form (CRF) data into the clinical trial database (Excel + REDCap system).

2. Maintain accurate logs for informed consent forms (ICFs), ensuring all patients are properly documented.

3. Record adverse events (AEs) and serious adverse events (SAEs), including severity, onset, and resolution dates.

4. Enter and verify lab test results (hematology, biochemistry, imaging findings) against original reports.

5. Record drug administration details (dose, route, frequency, duration).

6. Cross-check patient demographic and baseline data for consistency.

7. Flag missing, inconsistent, or duplicate entries for query resolution with clinical staff.

8. Prepare interim analysis datasets for monitoring committees.

9. Assist in creating compliance logs (protocol deviations, missed visits, early withdrawals).

10. Ensure data anonymization before reporting.

Deliverables:

• Excel master sheet with minimum 800 anonymized trial entries (demographics, labs, AE logs, treatment details).

• REDCap dataset export (CSV + JSON format).

• Word report (25–30 pages, APA 7th edition) including: Trial Overview, Data Entry Workflow, Data Cleaning Process, Interim Findings, Compliance Summary, Adverse Event Summary, References.

• PowerPoint presentation (20 slides) for the sponsor’s monitoring board, showing recruitment progress, AE summary charts, lab value trends, and treatment outcomes.

• PDF Regulatory Submission Packet including anonymized patient listings, AE log, and protocol deviation log.

• Data dictionary (Excel) showing all variable names, codes, and definitions.

Required Data Fields:

• Patient ID (anonymized code)

• Age / Gender

• Weight / Height / BMI

• Enrollment Date

• Study Arm (Drug / Placebo)

• Lab Test Results (Hemoglobin, WBC, Platelets, ALT, AST, Creatinine, etc.)

• Adverse Events (Type, Grade, Start/End Date, Outcome)

• Medication Dose, Frequency, Route

• Visit Dates / Missed Visits

• Protocol Deviations (Yes/No + Details)

• Withdrawal / Completion Status

• Notes / Comments

Special Instructions:

• Deadline: September 8th, 2025 (11:59 PM EST) – strict, no delays.

• All patient data must be de-identified before submission (replace names with unique study IDs).

• Must follow ICH-GCP standards for data integrity and audit readiness.

• Include 5+ charts/graphs (lab trends, AE frequencies, enrollment curves).

• Word report must reference minimum 15 peer-reviewed sources (APA 7).

• Cross-validation required: Excel totals must match REDCap exports.

• Data quality checks: ±5% tolerance allowed in lab ranges, otherwise flagged.

Material Source:
CRFs, scanned lab reports, ICF logs, drug dosing sheets, and monitoring visit notes (to be shared upon hire).