Clinical Research Coordinator II
SGS North America Inc.

Company Description

We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

Job Description

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.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Sets up and conducts studies in compliance with the protocol, SOPs, applicable regulations, and GCPs.
• Prepares, completes, organizes, and maintains 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 to protocol, SOPs and GCPs
• 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.
• Prepares and is accountable for all Test Material for managed studies.
• Adheres to the study budget.
• Monitor Compliance of panelists
• Complies with and understands safety and Operational Integrity procedures and processes.
• Completes other duties or tasks assigned by the Clinic Manager and/or Supervisor.

Qualifications

• Bachelor's in science, or other equivalent degrees - Required
  
• Understands basic concepts in clinical research and capable of learning and performing duties during clinical studies - Required
  
• Candidate must be bilingual (English and Spanish) - Required
  
• 2+ years relevant work experience or a combination of education and Work experience - Required

Additional Information

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 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.

Job Location

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