Senior Coordinator, Clinical Research

SGS•Richardson, TX

13h

About The Position

Responsible for coordinating and facilitating the daily activities that play a critical role in clinical studies according to the protocol, Good Clinical Practices (GCP), Standard Operating Procedures (SOP), and Federal and applicable regulations. This role involves setting up and conducting studies in compliance with protocol, SOPs, applicable regulations, and GCPs. The Senior Coordinator will prepare, complete, organize, and maintain all study documentation forms, including drafting protocol amendments, case report forms, and Electronic Data Capture (EDC) forms. They will also perform station and instrumentation duties, collect and record clinical information, and ensure clinic readiness for studies. This position requires ensuring staff understand and perform duties according to protocol, SOPs, and GCPs, and assists in training and mentoring new clinic staff. The role includes preparing for and conducting pre-study meetings, reviewing and providing feedback on draft protocols and recruiting materials, coordinating subject scheduling, ordering subject compensation, and preparing and managing Test Material. Additionally, the Senior Coordinator will adhere to study budgets, lead training workshops when applicable, assist in IRB and Regulatory Document submission/review, and provide excellent customer service to clients and panelists while maintaining positive interactions. Compliance with safety and Operational Integrity procedures is also essential.

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

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.