About this opportunity
SGS lists this Senior Clinical Research Coordinator II opportunity in richardson, Texas. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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 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 compensationPrepares and is accountable for all Test Material for managed studies
Adheres to study budget
Leads Training Workshops when applicable
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.
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
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.
Job Location
#J-18808-Ljbffr
Worksite address
richardson, TX, 75080, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.