Senior Coordinator, Clinical Research

SGS • Richardson, TX

6h

About The Position

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.

Requirements

• Understands basic concepts in clinical research and capable of learning and performing duties during clinical studies
• 2+ years relevant work experience

Nice To Haves

• CCRC/CCRA certification a strong plus

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior