- To serve as coordinator for clinical research studies and provides support to other study team members for research trials, studies, and projects within the confines of the study protocols as directed.
- To support protocol screening and study participant eligibility determination, working with more senior study team members to ensure compliance.
- To conduct all study activities in accordance with the protocol, Institutional Review Board (IRB) regulations, and Good Clinical Practice (GCP).
- May provide quality care to participants and their families within the area of clinical specialty.
- To assist with the life cycle of the study from start-up through maintenance to closure.
- To coordinate and organize 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 among 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, organizes, and participates in patient 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 study source documentation. Performs the informed consent process following GCP.
- Assists with the life cycle of the study from start-up through maintenance to closure.
- Follows the participant through the referral, consent, screening, treatment, and follow-up processes. Maintains clinical records and documentation including those associated with compliant billing practices. Performs clinical procedures as required by the protocol.
- 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 requirements.
- Reports safety, clinical care and/or study conduct issues to the appropriate parties.
- Tracks the study participant calendar and schedules/coordinates relevant visits and procedures.
- May employ strategies to maintain recruitment and retention rates. May prepare for study monitoring visits and assist with correcting findings.
- May process payments as needed and stays familiar with institutional financial systems.
- May assist with management of site supplies as needed.
- May develop or provide input for IRB documents. Assists with the management of investigational products (IP) as needed. Assists with the development of standard operating procedures (SOPs) for data quality assurance. Assists with study budgets as needed.
- Participates in study meetings and conference calls. Coordinates scheduling for participant visits among Principal Investigator (PI), pharmacy or others as needed.
- Uses the electronic medical record (EMR) as needed, including reporting procedure results.
- 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 I - University, United States - University of Alabama at Birmingham
Description
The University of Alabama at Birmingham is seeking a Clinical Research Nurse Coordinator I 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
Annually Salary Range:
$52, $85,400.00
Bachelor's degree in a related field is required. Work experience may substitute for education requirements. Currently licensed or eligible to be licensed as a Registered Nurse (RN) by the Alabama Board of Nursing required.
Preferred Knowledge/Skills/Experience:
