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Job detail

Clinical Research Coordinator II

SGS

Employer page
#SOP#Clinical Research#GCP#Federal Regulations#CCRC#Clinical Studies#Case Report Forms#EDC#CCRA#Protocol Amendments
#Science Degree
#Clinical Information Collection
Full TimeOn Site2-5 yrsPosted 1 day ago

Location

Richardson, Texas

Quick overview

Coordinate daily clinical study activities in compliance with protocols, GCP, and federal regulations. Manage study documentation, conduct pre-study meetings, and mentor new clinic staff.

Requirements summary

Requires a Bachelor's degree, preferably in science, and at least 2 years of relevant work experience. CCRC/CCRA certification is considered a strong advantage.

bachelor degreeprofessional certificateClinical DocumentationStandard Operating Procedures (SOP)Clinical Research CoordinationStaff MentoringElectronic Data Capture (EDC)Good Clinical Practices (GCP)Protocol DraftingClinical Study Reporting

Job description

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. 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 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 Reviews and provides feedback on draft protocols, recruiting materials, and draft clinical study reports

Qualifications

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 or a combination of education and Work experience CCRC/CCRA certification a strong plus

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.

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SGS

SG

Hiring organization

SGS

SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine...

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IndustryProfessional Services
TypePublic Company
Size10,001+ employees
HQBaar, Zug
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