Senior Clinical Research Coordinator II
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 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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
