Offer summary

Qualifications:

Minimum of two years experience in clinical research or related field., Bachelor's degree or relevant work experience., Knowledge of GCP, SOPs, IATA, and HIPAA regulations., Bilingual in Spanish is a plus..

Key responsibilities:

Assist in managing multiple clinical trials according to protocols.

Perform data entry, patient recruitment, and coordinate office visits.

Support clinical procedures such as phlebotomy, ECGs, and specimen handling.

Ensure compliance with regulatory standards and maintain study documentation.

Job description

Job Details

Job Location: Dermatology Treatment and Research Center (DTRC) - Dallas, TX

Position Type: Full Time

Education Level: 4 Year Degree

Salary Range: Undisclosed

Travel Percentage: Negligible

Job Shift: Day

Job Category: Research

Description

Clinical Research Assistant will perform work in one or all of the following areas Phlebotomy, Data Entry, and Administrative Assistant responsibilities in support of the clinical research team. The Clinical Research Assistant will assist in the management of multiple clinical trials according to the study protocol, perform collection of clinical data points, and provide seamless customer service to the patients attending the site.

Responsibilities Include but not limited to:

Complete training and ensure adherence of GCPs, SOPs, IATA, and HIPPA
Ensure compliance with all clinical trial protocols
Ensure compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC, and HIPPA.
Assist research staff with Phase II-IV clinical trials from start through closure
Enter visits, patient recruitment in Real Time Clinical Trial Management System (CTMS)
Aid research department is meeting contracted and expected recruitment goals
Engage in quality assurance of all study documents and data prior to monitoring visits
Support central and local marketing campaigns by entering recruitment data, contacting patients and scheduling.
Coordinate office visits for trial participants based on the protocol
Perform phlebotomy, collect, process and ship clinical specimens
Assist in patient care visits and procedures according to protocol
Receive medication, confirm temperature in range and maintain temperature logs
Perform ECGs
Engage in patient recruitment
Assist with entry into Electronic Data Capture (EDC) data queries are resolved
Participate in Investigator meetings and trainings during the course of the trial
Generate PowerPoint presentations
Create and organize new patient charts, lab and other required supplies prior to the patient visit.
Gain access to Institutional Review Boards.
Maintain regulatory binders, CRFs, subject charting, and source documents
Maintain the Investigator Site Files
Assist with keeping Institutional Review Boards (IRB) documents, Electronic Data Capture (EDC) Clinical Trials Management System (CTMS) and Interactive Web Response Systems (IWRS) current
Will support central and local marketing campaigns by contacting potential subjects and scheduling

Qualifications

Possess a minimum of two (2) years experience in the clinical research or closely related field
Bachelors degree or relevant work experience.
Bilingual (Spanish), a plus.

Required profile