CLINICAL RESEARCH COORDINATOR II
The University of Alabama at Birmingham (UAB), Ped - Hematology/Oncology Department, is seeking a Clinical Research Coordinator II to join their team.
General Responsibilities- To serve as coordinator for studies and provide support to other team members within the confines of the protocol as directed.
- To support screening and participant eligibility determination, working with more senior team members to ensure compliance.
- To conduct activities in accordance with the protocol, regulations and Good Clinical Practice (GCP).
- To assist with the study life cycle from start-up to closure, i.e., collecting and recording data, recruiting and performing follow-up with participants, scheduling visits and assisting in coordination of lab and fieldwork.
- Screens and enrolls participants on clinical trials. Conducts informed consent per GCP guidelines.
- Conducts patient visits per protocol schedule of events. Documents adverse events, medications, and procedures conducted at each visit. Research sample collection, processing and shipment. Administers questionnaires and other procedures as trained.
- Documents Adverse Events (AEs) and Serious Adverse Events (SAEs) as required by protocol and regulatory guidance. Completing and submitting expedited SAE reports per protocol.
- Conducts study initiation visits. Conducts point-of-care protocol training. Assists PI and nursing in developing protocol orders. Attends team meetings and educational training as required
- Performs other duties as assigned.
- Prefer Clinical Research experience, science and medical terminology, assisting with the coordination of research activities involved in conducting Oncology clinical trials.
- Knowledge of lab practices.
- Knowledge of GCP and ICH Guidelines and ability to follow established regulations, procedures, and protocols.
- Demonstrated ability to gather data and document procedures
- Ability to plan, work, and coordinate multiple projects
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