- To serve as primary coordinator for clinical research studies and supporting more senior team members.
- To provide a lead role in protocol screening and participant eligibility determination working alongside other team members to ensure compliance.
- May provide oversight to junior clinical research coordinators (CRC) and clinical research nurse coordinators (CRNC) in review of study documents.
- To conduct all study activities in accordance with the protocol, Institutional Review Board (IRB) regulations, and Good Clinical Practice (GCP).
- To provide quality care to participants and their families within the area of clinical specialty.
- To coordinate the life cycle of the study from start-up through maintenance to closure.
- To manage participant care including recruitment, screening, scheduling, consenting, conducting visits, and collecting various assessments such as adverse event (AE) information or questionnaires.
- To perform the informed consent process following GCP.
- To act as a liaison between the clinical and research staff, departments, ancillary services, and the study sponsor to ensure protocol compliance throughout the study.
- Conducts all study activities in accordance with the protocol, IRB regulations, and GCP.
- Coordinates the life cycle of the study from start-up through trial maintenance to closure. Manages participant care including recruitment, screening, scheduling, consenting, conducting visits, and collecting various assessments such as adverse event (AE) information or questionnaires. Documents and reviews medical history to determine compliance with eligibility requirements. Develops/prepares study source documentation. Performs the informed consent process following GCP.
- Promotes continuity of care through consultations with participants, families, and medical and nursing staff.
- In collaboration with others, as needed, 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.
- Reports safety, clinical care and/or study conduct issues to the appropriate parties.
- Communicates specific study requirements to internal and external parties as needed.
- Performs clinical procedures as required by the protocol. Prepares for and participates in study monitoring visits and corrects and reports findings as needed. May serve as a resource person within the area of clinical expertise.
- Administers or distributes investigational medications to study participants within confines of the study protocol and institutional policy.
- Uses the electronic medical record (EMR) as needed, including reporting procedure results.
- May process and maintain lab specimens.
- May assist with the development of protocols.
- Maintains clinical records and documentation including those associated with compliant billing practices.
- Manages site supplies as needed.
- May assist with the development of documents related to participant safety and security.
- May provide input on research protocols including study feasibility.
- Maintains a working nursing knowledge of the department specialty, drafts documents or policies, collects records, and assists with the preparation of data for publication. May perform general nursing duties.
- Performs other duties as assigned.
- Strongly prefer Oncology and/or Clinical Research experience
- Experience with the management of data and of study patient care
- Knowledge of regulatory/compliance affairs as it pertains to clinical research
- Knowledge of protocol financial functions
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Clinical Research Nurse Coordinator II - University, United States - University of Alabama at Birmingham
Description
The University of Alabama at Birmingham is seeking a Clinical Research Nurse Coordinator II in the O'Neal Comprehensive Cancer Center.
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.
The link to our website is:
General Responsibilities
Annual Salary Range:
$60, $98,855.00
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirements. Currently licensed as a Registered Nurse (RN) by the Alabama Board of Nursing required.
Preferred Knowledge/Skills/Experience:
