Company:  Confidential

Job Title: Clinical research coordinator

Job Number: 79446

Location: Dallas, US

Job Description

We are currently in search of an enthusiastic and self-driven clinical research coordinator. Our research focuses on the role of nutrition and food in pediatric GI diseases. As a member of our team, you will have the opportunity to contribute to cutting-edge research in the field of pediatric nutrition. We will provide you with comprehensive guidance and mentorship to ensure your success in this role. We expect our ideal candidate to commit to a minimum of two years of service with our group.

 

Summary:

Under the direct supervision of the study team, assists in the coordination of the details of the human research subject study and documentation concerning study protocols.

 

Job Responsibilities

·      Data management

·      Laboratory procedures

·      Order materials/supplies

·      Adhere to an IRB approved protocol

·      Participate in the informed consent process of study subjects

·      Support the safety of clinical research patients/research participants

·      Coordinate protocol related research procedures, study visits, and follow-up care

·      Screen, recruit and enroll patients/research participants

·      Document and report adverse events

·      Maintain study source documents

·      Submit basic IRB reports

·      Complete case report forms (paper and electronic data capture)

·      Maintain study source documents

·      Understand good clinical practice (GCP) and regulatory compliance

·      Educate subjects and family on protocol, study intervention, etc.

·      Comply with Institutional policies, standard operating procedures (SOPs) and guidelines

·      Comply with federal, state, and sponsor policies

 

Related responsibilities

·      Manage essential regulatory documents

·      Register study on ClinicalTrial.gov

·      Complete case report forms (paper & electronic data capture) and address queries

·      Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie, DSMB, independent safety officer)

·      Facilitate pre-study, site qualification, study initiation, and monitoring visit

·      Facilitate study close out activities

·      Coordinate research/project team meetings

·      Collect, process and ship laboratory specimens

·      Schedule subject visits and procedures

·      Retain records/archive documents after study close out

 

Required Education: Associate degree or active enrollment in a Bachelor’s Degree Program

Recommended Experience: Two (2) years of relevant clinical research experience.

 

Additional Technical Requirements

·      Excellent verbal and written communications skills

·      Excellent time management skills

·      Ability to collaborate with stakeholders at all levels

 

What we provide:

·      A competitive compensation package with comprehensive health and wellness benefits

·      Joining the vibrant research community at UT Southwestern Medical Center and Children’s Medical Center

·      Hands-on training and ongoing skill-building in clinical research, human-subject trials, and microbiome analysis

·      Opportunities to contribute to research publications

·      Career mentorship to foster professional growth and support in achieving your career goals

Application Deadline: 2024-10-01

 

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