CLINICAL RESEARCH COORDINATOR II
University of Alabama at Birmingham
Description
The University of Alabama at Birmingham (UAB), School of Medicine, Division of Clinical Immunology and Rheumatology, is seeking a Clinical Research Coordinator II to conduct the following: screening and enrolling participants in rheumatology observational studies and clinical trials; develop and maintain source documents per protocol and GCP guidelines, conduct informed consent per GCP guidelines; conduct patient visits per protocol; document adverse events, medications, and procedures conducted at each visit; prepare lab kits for each patient visit; administer study questionnaires; and other procedures as trained. The CRC II will compile and summarize data, develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected. This position will serve as a mentor to junior staff, conduct protocol training, assist PIs to develop regulatory protocols and documents, as well as attend team meetings and educational training as required.
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
Screens and enrolls participants in Rheumatology clinical trials and observational studies. Ensures eligibility, protocol adherence, and proper informed consent.
Conducts and documents patient visits according to the protocol schedule of events.
Prepares Investigational Product (IP) dispensing orders for Investigational Drug Services (IDS) pharmacy and treatment orders for the infusion nurses, as needed.
Accurately documents adverse events, medications, and procedures conducted at each visit in a timely manner.
Works with sponsors and PI to address study data queries.
Assists the PI in developing protocol documents, manuals, presentations, and reports. Ensures readiness for audits and monitoring visits.
Attends team meetings and educational training as required.
In conjunction with Investigators, plans and implements the clinical protocol's goals and objectives.
Compiles, edits, and submits written reports for both internal and external administrative offices.
Serves as a mentor to junior staff, including student assistants and CRC I.
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..
Experience with the coordination of clinical research activities, particularly IP clinical trials.
Management of clinical research data.
Knowledge of regulatory/compliance affairs as it pertains to clinical research.
Ability to work in a team environment successfully.
Excellent organizational and time management skills.
Exceptional communication skills.
Consistent attention to detail.
UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.