What are the responsibilities and job description for the CLINICAL RESEARCH DATA COORDINATOR II position at UAB Health System?
The University of Alabama at Birmingham (UAB), Med - Hematology & Oncology is seeking a Clinical Research Data Coordinator II. Sickle Cell Research is seeking a Clinical Research Data Coordinator II who works independently to obtain, abstract, and code complex clinical information from multiple sources (medical records, research records, etc.) for Gene Therapy research subjects.
General Responsibilities
- To design, implement and maintain clinical-based relational database management systems.
- To ensure operation and maintenance of departmental systems for data organization, collection, retrieval, and reporting purposes.
- To develop methods for tracking and reporting data and monitors incoming and outgoing data to ensure data integrity and compliance with applicable regulatory agency policy.
- To research and collect information and enter data into established external data marts specific to clinical discipline and retrieves as necessary.
- To perform a variety of statistical analyses and summarizes results.
Key Duties & Responsibilities
- Accurately captures, in a timely manner, subject information into various study specific data capture systems (electronic and paper).
- Uses knowledge of various disease states and the ability to determine the appropriate clinical information to report. Information reviewed may include, but is not limited to treatment records, clinical and radiographic evaluations, diagnostic test results, and records of surgery.
- Supports principal investigator and the research team with administrative, data collection and entry in the management to support the day-to-day execution of clinical trials from start up to close out; ensure adherence to compliance with established SOP's, GCP, IRB and FDA and other applicable regulatory requirements in the execution of clinical trials.
- Designs, implements, and maintains clinical-based relational database management systems.
- Ensures operation and maintenance of departmental systems for data organization, collection, retrieval, and reporting purposes.
- Develops methods for tracking and reporting data and monitors incoming and outgoing data to ensure data integrity and compliance with applicable regulatory agency policy.
- Researches and collects information, enters data into established external data marts specific to clinical discipline and retrieves as necessary.
- Maintains study's compliance with institutional requirements.
- Serves as liaison with medical staff, University Departments, ancillary departments and/or satellite facilities. Information reviewed may include, but is not limited to treatment records, clinical and radiographic evaluations, diagnostic test results, and records of surgery.
- Obtains required forms, reports, and other pertinent information required for subject eligibility analysis.
- Assists in analysis and quality assurance of clinical trial research information.
- Coordinates routine monitoring and audit visits with industry sponsor pharmaceutical representatives or clinical research organizations.
- Coordinates preparation of data for audits and monitoring visits.
- Provides sufficient, appropriate, and timely responses to sponsor verbal and written queries.
- Attends protocol-specific training including but not limited to Study Investigator's Meeting, Study Initiation, and Study Start Up.
- Participates in conference calls and/or meetings with vendors.
- Attends approved off-site meetings and conferences.
- Maintains working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines as well as comprehensive understanding of the clinical trial process, including but not limited to eligibility and disease processes.
- Attends weekly team meetings and participate in training and educational opportunities.
- Performs other duties as assigned.
Annual Salary Range: $45,395 - $73,770
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.
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, religion, sexual orientation, gender identity, gender expression, 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.
Primary Location: University
Job Category: Clinical Research
Organization: 311402200 Med - Hematology & Oncology
Employee Status: Regular
Shift: Day/1st Shift
Salary : $45,395 - $73,770
