Clinical Research Coordinator I

CARUM RESEARCH INC; Dallas (TX); On-site; USD 48,000 - 65,000; Full time

Job summary

CARUM RESEARCH INC. in Dallas, TX seeks a Clinical Research Coordinator (CRC) to manage trials, review protocols, and ensure SOP compliance.

The role involves data entry, coordinating with sponsors, IRB, and CROs, plus ongoing training in good clinical practice. Responsibilities include participant visits (in-person/virtual), document development, regulatory submissions, and safeguarding study confidentiality while ensuring ethical standards are met.

Qualifications

• High School Diploma or GED with 3 years health care, customer service, or administrative support experience.
• Two years of college in a scientific, health-related, or business program and one year of related health care, customer service, or administrative experience.
• Licensed as an LPN/LVN with one year of related experience.
• Bachelor's or higher in a scientific, health-related, or business field.

Responsibilities

• Communicates with study investigators, sponsors, IRB, and others about protocols and recruitment.
• Assists in recruitment strategy development and participant screening.
• Conducts in-person, virtual, or telephone-based study visits.
• Reviews records, attends recruitment events, and interacts with participants.
• Develops flow sheets and source documents for the study.
• Maintains accurate study documents and audits CRFs against source data.
• Implements IRB-approved protocol changes to visits and documentation.
• Participates in sponsor webinars, teleconferences, and investigator meetings.

Skills

Attention to detail

Teamwork

Multi-tasking

Communication

Customer service

Education

High School Diploma or GED

Two years of college in scientific/health/business + 1 year related experience

LPN/LVN license

Bachelor's/Master/MD/PhD in science/health/business

Job description

Job Details: Job Location: CARUM RESEARCH - DALLAS, TX 75243 Position Type: Full Time

Job Summary

The Clinical Research Coordinator (CRC) manages clinical trials and other research projects. The CRC reviews study protocols, manuals of operation, and other relevant SOPs to guide study visits with subjects and ensure all procedures are performed accordingly; handles administrative activities generally associated with the conduct of research; continuously maintains up to date informed consent with subjects; enters information into the electronic data capture (EDC) system; communicates with the sponsor, monitors, auditors, clinical research organization (CRO), and other governing bodies; documents and communicates adverse events & serious adverse events; resolves study queries; and participates in trainings, particularly in good clinical practice. With appropriate credentialing/training may perform phlebotomy and specimen collection. May perform supervisory duties and train less experienced personnel.

Duties and Responsibilities

• Communicates clearly with study investigators, sponsors, director, IRB, and others regarding study protocols, recruitment, adverse events, etc.
• Assists in developing recruitment strategies and performs screening with potential participants.
• Performs in-person, virtual, and/or telephone-based research visits.
• Reviews patient records, attends recruitment events, directly interacts and cares for research participants
• Develops flow sheets, source documents, and other study related documents.
• Maintains up to date and accurate study documents. Reviews case report forms and audits for accuracy with source documents.
• Implements IRB approved protocol changes to visits and source documentation.
• Participates in sponsor provided webinars, teleconferences, and investigator meetings.
• Prepares/reviews documents for regulatory submission.
• Ensures study information is kept secure and confidential.
• Supervises collection of study specimens and processes specimens.
• Monitors scheduling of procedures, screening, specimen shipping/handling, laboratory kits, and coordinates other services as needed.
• Ensures adequate temperature regulation and documentation for investigational products, laboratory supplies, and other temperature-specific materials.
• Educates participants on investigational products and administers investigational products.
• Ensures compliance and ethical standards are maintained throughout the conduct of the study.
• Provides any other duties and responsibilities as determined by management and physician leadership.
• Abides by all HIPAA and confidentiality regulations and policies.

Supervisory Responsibilities

May perform supervisory duties and train less experienced personnel.

Required Skills/Abilities

• Must be attentive to detail
• Demonstrate a strong history of working in a team environment
• Ability to multi-task
• Have strong communication skills and customer service

Education and Experience

• High School Diploma or GED and three years of health care, customer service, or administrative support experience OR
• Two years of college in a scientific, health-related, or business program and one year of health care, customer service, or administrative support experience
• Licensed as an LPN/LVN and one year of health care, customer service, or administrative support experience
• Bachelors degree, Masters degree, MD, PhD in a scientific, health-related, or business program

Physical Requirements

• Ability to lift up to 30 pounds with frequent lifting and/or carrying of objects that weighing 10 pounds
• Ability to walk and/or stand for significant amounts of time
• Providing assistance with patient mobility and transfers