Clinical Research Coordinator II

SGS • Richardson, TX

1d

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. 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

Requirements

• 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

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 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

What This Job Offers

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