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University of Alabama at Birmingham · 10 hours ago

CLINICAL RESEARCH COORDINATOR II

Greater Birmingham, Alabama Area

Full-time

Onsite

Mid Level

$50K/yr - $81K/yr

3+ years exp

The University of Alabama at Birmingham (UAB) is seeking a Clinical Research Coordinator II to support various clinical studies. The role involves participant recruitment, data collection, and ensuring compliance with research protocols while training junior team members.

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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

Schedules participants and conducts visits for all studies independently, including baseline and post-treatment visits and neuro-imaging visits. This includes proactively reaching out to treating Psychologists and scheduling follow-up visits to align with anticipated treatment completion

Administers computer tasks during fMRI and outside of the scanner. Administers questionnaires and collects blood and saliva samples

Trains others to conduct and document visits and protocol-specific testing/interviews

Assists with development and follows procedures and documentation of study payment in a timely fashion

Participates in recruitment of participants through screening efforts, including pre-screening medical records of potential participants on the waitlist for the FND treatment clinic, administering a structured interview (QuickSCID-5) for the purposes of matching FND patients and controls, and consenting participants according to regulatory guidelines

Employs strategies to maintain recruitment and retention rates. Provide oversight and training to study team members who screen and consent participants

Maintains subject-level documentation for all studies independently

Provides oversight and training to study team members who maintain subject-level documentation, including documentation in the Electronic Medical Record

Maintains training requirements and develops solutions to proactively ensure study team members' compliance with training requirements

Independently maintains appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of records, etc

Maintains study's compliance with institutional requirements and other policies (e.g., NIH Public Access policy, ct.gov, Research Data Security Plans, etc.)

Oversees maintenance of Delegation of Authority Logs and training of key personnel on study-specific duties

Involved in the study feasibility process and may assist in budget development and billing procedures

Prepares and submits multiple levels of research documentation (i.e. IRB, IND, or FDA submissions, educational materials, reports, grant renewal reports, and study forms)

Processes blood and saliva samples in preparation for storage in the freezer

Manages site supplies (e.g., Vacutainers, butterfly needles, gauze, medical tape, Salivettes) and performs administrative duties in support of research conduction as needed

Trains junior staff in the ethical conduct of research and provides guidance on strategies used to maintain safety

Summarizes and clarifies for study teams the professional guidelines and code of ethics related to the conduct of clinical research

Collects adverse event information independently and submits adverse event reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms)

Completes Case Report Forms (CRF) according to protocol

Assists with the development of standard operating procedures (SOPs) for data quality assurance

Organizes patient enrollment planning

Conducts quality assurance activities

Compiles and analyzes data

Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected. This includes transferring neuroimaging data to a shared server and uploading data onto the supercomputer for analysis

Maps protocol data flow

Predicts areas of vulnerability for a protocol's data flow plan

Determines areas where data provenance may be compromised

Attends study, departmental, and institutional trainings and meetings as required, including weekly scheduled lab meetings, and performs other duties as assigned

Performs other duties as assigned

Qualification

Clinical Research CoordinationClinical Practice (GCP)Data ManagementNeuroscience KnowledgePatient RecruitmentTraining SkillsQuality AssuranceEthical Conduct of ResearchDocumentation Skills