CLINICAL RESEARCH COORDINATOR III

Clinical Research Coordinator III

The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center, is seeking a Clinical Research Coordinator III. The O'Neal Comprehensive Cancer Center is one of 51 NCI-designated comprehensive cancer centers in the United States and is the only one in Alabama and in the Deep South region. A comprehensive designation also means UAB Medicine patients have access to leading-edge treatments or clinical trials that they may not otherwise have at local community hospitals or smaller cancer centers. For many, an NCI designation can hold the key to survival. On campus and around Birmingham, the O'Neal Cancer Center is a significant part of our economic powerhouse. The O'Neal Cancer Center powers more than 400 scientists and physician-scientists, cares for 20,000 patients annually, and is home to more than 160 employees, plus all the physicians and clinical staff engaged in cancer patient care.

General 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).

Key Duties & Responsibilities:

• 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. May lead CRC and CRNCs.
• Responsible for conducting all study activities in accordance with the protocol, IRB regulations, and Good Clinical Practice (GCP).
• Provides quality patient care to patients and their families within the area of clinical specialty.
• Manages the life cycle of the clinical trial from study start-up through trial maintenance to study closure.
• Coordinates and organizes patient care, including recruitment, screening, scheduling, consenting, conducting visits, and collecting various assessments such as adverse event (AE) information or questionnaires.
• Performs the informed consent process following GCP.
• 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 the 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.
• Completes OnCore worksheet to ensure proper protocol billing.
• Performs other duties as assigned.

Annual Salary Range: $60,835 - $98,855

Qualifications:

• 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.
• Preferences: 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. Working knowledge of related scientific and clinical terminology. Leadership skills. Problem-solving 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.