CLINICAL RESEARCH COORDINATOR II
University of Alabama at Birmingham
Description
The University of Alabama at Birmingham (UAB), Med - Pulmonary/Allergy/Critical Care, is seeking a Clinical Research Coordinator II.
We are seeking a Clinical Research Coordinator II to assist the research team as the participant-facing lead for ongoing clinical studies. The qualified applicant will direct subject enrollment, recruitment, and retention, as well as assist in participation in research trials. As a member of the research team, they will provide administrative support in a variety of related tasks (e.g., compiling minutes with the assistance of tools such as the generative AI Zoom companion, preparing progress reports alongside the laboratory project management team, etc.). Critically, the qualified applicant will also interface with the Birmingham Veterans' Association (VA), serving similar roles on projects funded through VA mechanisms, which constitute a sizable portion of research in our laboratory. These duties will be primarily related to trial management and administration.
General Responsibilities
To serve as coordinator for studies and provide support to other team members within the confines of the protocol as directed.
To support screening and participant eligibility determination, working with more senior team members to ensure compliance.
To conduct activities in accordance with the protocol, regulations and Good Clinical Practice (GCP).
To assist with the study life cycle from start-up to closure, i.e., collecting and recording data, recruiting and performing follow-up with participants, scheduling visits and assisting in coordination of lab and fieldwork.
Key Duties & Responsibilities
Serves as a liaison with medical staff, University Departments, ancillary departments and/or satellite facilities.
Organizes patient enrollment planning.
Conducts quality assurance activities. May compile and analyze data.
Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected.
Participates in the recruitment of participants through screening efforts, including the conduction of the consent process according to regulatory guidelines.
Coordinates care and/or follow-up functions of the study, including planning and developing related activities.
Arranges access to study medications, as needed, including authorization for prescriptions.
Employs strategies to maintain recruitment and retention rates.
Involved in the study feasibility process and may assist in budget development and billing procedures.
Prepares and submits multiple levels of research documentation (i.e. IRB, IND, or FDA submissions, educational materials, reports, grant renewal reports, and study forms). May manage investigational products (IP), including their administration to participants.
Employs the required system (including personnel) for handling, dispensing, and documenting IP for sponsored protocols.
In conjunction with Investigators, plans and implements the clinical protocol's goals and objectives.
Compiles, edits, and proofs written reports for both internal and external administrative offices.
Provides data for the creation of study budgets as needed.
Completes Case Report Forms (CRF) according to protocol.
Documents Adverse Events (AEs) and Serious Adverse Events (SAEs) as required by protocol and regulatory guidance.
Assists with the development of standard operating procedures (SOPs) for data quality assurance.
Performs vendor analysis and equipment configuration as needed. May perform a variety of medical procedures and assist in developing orders in the Electronic Medical Record (EMR).
Under the oversight of the Investigator, develops protocols, identifies efficiencies, and improves processes.
Serves as a mentor and provides guidance to junior staff, including student assistants.
Maintains compliance with federal, state, and accrediting agencies (sponsors).
Maintains any required documentation. Has a working knowledge of institutional and departmental policies and processes.
Processes and maintains lab specimens.
Manages site supplies and performs administrative duties in support of research conduction as needed.
Attends study, departmental, and institutional trainings and meetings as required.
Performs other duties as assigned.
Annual Salary Range: $50,050 - $81,330
Qualifications
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.