CLINICAL RESEARCH COORDINATOR III jobs in United States
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University of Alabama at Birmingham · 2 months ago

CLINICAL RESEARCH COORDINATOR III

The University of Alabama at Birmingham (UAB) is seeking a Clinical Research Coordinator III to serve as the primary coordinator for interventional trials at the O'Neal Comprehensive Cancer Center. This role involves managing the clinical trial lifecycle, ensuring compliance with protocols and regulations, and providing quality patient care.

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Responsibilities

To serve as a lead coordinator by providing oversight to less experienced staff to ensure quality and regulatory compliance with clinical research operations
To coordinate and manage the research study lifecycle from start-up through close-out
To coordinate and conduct all applicable clinical and administrative activities required by the protocol, such as screening, scheduling, consenting, assessing, ordering, collecting, documenting, and shipping under the auspices of Good Clinical Practice (GCP)
Provides a lead role in protocol screening and participant eligibility determination working alongside other team members to ensure compliance
Provides oversight to clinical research coordinators (CRC) I and IIs and clinical research nurse coordinators (CRNC) I and IIs in review of study start up, SIV planning, subject management, data query resolution and source document development including review of study documents including but not limited to flowsheets, pharmacy orders, labs, and adverse events
Communicates effectively with CRC and CRNC regarding lab reports and adverse events to ensure protocol compliance with dosing
In conjunction with the PI or Director, interprets and applies current research findings in the area of clinical specialty and reports findings in professional journals and local, state, and national conferences
Schedules/coordinates patient visits and procedures, and tracks the study participant calendar per protocol schedule of events
Coordinates patient care and/or patient follow-up functions of the clinical study, including planning and developing related activities
Arranges access to study medications, including authorization for prescriptions
Employs strategies to maintain recruitment and retention rates
In collaboration with the CTO regulatory team and coordinators, completes and submits Adverse Event (AE) and Serious Adverse Event (SAE) reports in a timely manner and in compliance with FDA, sponsor, and institutional policies
May perform a variety of medical procedures
Completes OnCore worksheet to ensure proper protocol billing
Performs other duties as assigned

Qualification

Clinical Research CoordinationClinical Practice (GCP)Certified Clinical Research Coordinator (CCRC)Clinical Research Regulatory AffairsOncology Clinical TrialsLeadership SkillsProblem-Solving SkillsOrganizational SkillsWritten Communication SkillsVerbal Communication Skills

Required

Bachelor's degree in a related field and five (5) years of related experience required
Work experience may NOT substitute for education requirement
Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred

Preferred

Clinical research experience
Ability to lead others in the coordination of research activities involved in conducting Oncology clinical trials
Knowledge of clinical research regulatory/compliance affairs
Problem-solving skills
Working knowledge of related scientific and clinical terminology
Leadership skills
Presentation skills
Prioritization skills
Organizational skills
Written and verbal communication skills
Ability to walk minimally one mile a day and lift 5 - 10 pounds daily

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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