CLINICAL RESEARCH COORDINATOR II jobs in United States
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University of Alabama at Birmingham · 1 month ago

CLINICAL RESEARCH COORDINATOR II

The University of Alabama at Birmingham (UAB) is seeking a Clinical Research Coordinator II. This role involves coordinating clinical studies, supporting patient screening and recruitment, and ensuring compliance with regulatory guidelines throughout the study life cycle.

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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
Serves as a liaison with medical staff, University Departments, ancillary departments and/or satellite facilities
Organizes patient enrollment planning
Conducts quality assurance activities. May compile and analyze data
Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected for MFM studies
Maintains compliance with federal, state, and accrediting agencies (sponsors)
Maintains any required documentation. Has a working knowledge of institutional and departmental policies and processes
Participates in the recruitment of participants through screening efforts, including the conduction of the consent process according to regulatory guidelines
Coordinates care and/or follow-up functions of the study, including planning and developing related activities
Arranges access to study medications, as needed, including authorization for prescriptions
Employs strategies to maintain recruitment and retention rates. 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). May manage investigational products (IP), including their administration to participants
Employs the required system (including personnel) for handling, dispensing, and documenting IP for sponsored protocols. In conjunction with Investigators, plans and implements the clinical protocol's goals and objectives
Compiles, edits, and proofs written reports for both internal and external administrative offices
Provides data for the creation of study budgets as needed
Completes Case Report Forms (CRF) according to protocol
Documents Adverse Events (AEs) and Serious Adverse Events (SAEs) as required by protocol and regulatory guidance
Assists with the development of standard operating procedures (SOPs) for data quality assurance
Performs vendor analysis and equipment configuration as needed. May perform a variety of medical procedures and assist in developing orders in the Electronic Medical Record (EMR)
Under the oversight of the Investigator, develops protocols, identifies efficiencies, and improves processes
Serves as a mentor and provides guidance to junior staff, including student assistants
Processes and maintains lab specimens
Manages site supplies and performs administrative duties in support of research conduction as needed
Attends study, departmental, and institutional trainings and meetings as required
Performs other duties as assigned

Qualification

Clinical Research CoordinationClinical Practice (GCP)Data ManagementPatient RecruitmentRegulatory SubmissionsEffective CommunicationTeam Collaboration

Required

Bachelor's degree in a related field
Three (3) years of related experience
Willingness to alternate between day and night shifts
Effective verbal and written communication
Ability to work independently as well as within a team

Company

University of Alabama at Birmingham

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The University of Alabama at Birmingham is a public university in located in Birmingham, Alabama.

Funding

Current Stage
Late Stage
Total Funding
$45.14M
Key Investors
American Academy of Orthopaedic SurgeonsParkinson's FoundationNational Institutes of Health
2023-12-01Grant· $0.02M
2023-07-25Grant
2023-06-26Grant

Leadership Team

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Martha Bidez
Professor and Director, Advanced Safety Engineering & Management
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