Clinical Research Coordinator II at SGS North America Inc. in Richardson, Texas

Job Title

Responsible for coordinating and facilitating the daily activities that play a critical role of the clinical studies according to the protocol, Good Clinical Practices (GCP), Standard Operating Procedures (SOP), and Federal and applicable regulations.

• Sets up and conducts study in compliance with protocol, SOPs, applicable regulations and GCPs
• Prepares, completes, organizes and maintains of all study documentation forms, including drafting protocol amendments, case report forms, Electronic Data Capture (EDC), and other study specific documents
• Performs station and instrumentation duties on other studies as assigned, including the collection and recording of clinical information
• Assures for assigned studies, clinic is set up at least 30 minutes prior to the study start
• Report to clinic on-time for all other studies
• Assures that staff working on their managed studies understand and are performing duties according to protocol, SOPs and GCPs
• Assists in training and mentoring new clinic staff
• Prepares for and conducts pre-study meetings as well as other meetings and processes as deemed necessary by management
• Reviews and provides feedback on draft protocols, recruiting materials, and draft clinical study reports
• Coordinates scheduling subjects for visits
• Responds to queries from Quality Assurance and Statistics departments
• Orders checks for subject compensation
• Prepares and is accountable for all Test Material for managed studies
• Adheres to study budget
• Leads Training Workshops when applicable
• Initiate electronic questionnaire creation
• Assist in IRB and Regulatory Document submission/review
• Provides excellent customer service to clients and panelists and maintains a positive and respectful interaction with peers and supervisors.
• Complies with and understands safety and Operational Integrity procedures and processes.

• Bachelor's degree - preferably in science or other equivalent degree
• Understands basic concepts in clinical research and capable of learning and performing duties during clinical studies
• 2+ years relevant work experience
• CCRC/CCRA certification a strong plus

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations.

The requirements listed above are representative of the knowledge, skills, and/or abilities required. This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call  for assistance and leave a message.

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