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- To manage all aspects of assigned clinical studies including education.
- To develop protocol-specific systems and documents.
- To act as a consultant within area of clinical expertise.
- To identify various stakeholders to ensure adequate design, implementation, and testing of study aims.
- To assess and determine solutions for operational shortcomings for data procurement in protocol design.
- To maintain familiarity with appropriate Good Clinical Practice (GCP) guidelines and regulations.
- 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 to conduct 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 with 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.
- Provides a lead role in protocol screening and participant eligibility determination working alongside other team members to ensure compliance.
- Communicates effectively with CRC and CRNC regarding lab reports and adverse events to ensure protocol compliance with dosing. In conjunction with PI or Director, interprets and applies current research findings in 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 insure proper protocol billing.
- Performs other duties as assigned.
- Bachelor's degree in a related field and five (5) years of related experience required.
- Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP).
- Clinical Research Experience.
- Ability to lead others in the coordination of research activities in conducting Oncology clinical trials.
- Knowledge of clinical and regulatory/compliance affairs.
- Problem solving skills.
- Working knowledge of related scientific and clinical terminology.
- Leadership skills.
- Presentation skills.
- Prioritization and organizational skills.
- Excellent written and verbal communication skills.
- Ability to walk minimally one mile a day and lift five to ten pounds daily.
Clinical Research Coordinator III - Santa Cruz, United States - University of Alabama at Birmingham
Description
The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center, is seeking a Clinical Research Coordinator III. The Clinical Research Coordinator III serves as primary coordinator for interventional trials and supporting more senior team members.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. The link to our website isPlease attach a current resume with this application.
General Responsibilities
Annual Salary Range:
$60, $98,855.00
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