311131true311131falseSubmission for the position CLINICAL RESEARCH REGULATORY COORDINATOR III - Job Number T233145false311131falsetrueCLINICAL RESEARCH REGULATORY COORDINATOR IIIT233145 The University of Alabama at Birmingham UAB ONeal Comprehensive Cancer Center is seeking a Clinical Research Regulatory Coordinator III. This position will report to the Director of Quality Management and will be responsible for the review of data from clinical trial initiation throughout the trials duration. Will assist in assuring compliance with the ONeal Comprehensive Cancer Center standards and all applicable regulations with a strong emphasis on regulatory compliance. The Quality Management department is responsible for reviewing study data medical records case report forms monitoring letters drug accountability and regulatory files. It oversees Quality Assurance compliance with study protocols and ensures study guidelines are followed in accordance with Good Clinical Practices. Emphasis on regulatory documents. The ONeal 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 ONeal Cancer Center is a significant part of our economic powerhouse. The ONeal Cancer Center powers more than 400 scientists and physician-scientists cares for 20000 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 httpswww.uab.eduonealcancercenter Please attach a current resume with this application. General Responsibilities To prepare and submit multiple levels of research documentation i.e. IRB submissions educational materials reports grant renewal reports and study forms. To prepares and maintain FDA applications for Investigational New Drugs INDs and Investigational Device Exemptions IDEs. To lead the implementation of study specific regulatory processes of a moderate to complex nature. To conduct internal quality assurance audits of regulatory files as well as programs reports and teams working within clinical trial operations. To design and implement quality initiatives ensuring effective and efficient clinical processes. Key Duties & Responsibilities Audits Investigator Initiated Trials IIT Cooperative trials and pharmaceutical-sponsored trials. Conducts internal quality assurance audits of regulatory files. Assists in the design and implementation of quality initiatives ensuring effective and efficient clinical processes. Verifies compliance with protocols Standard Operating Procedures SOPs FDA ICH and GCP regulations. Maintains Quality Assurance data files. Prepares accurate audit reports makes recommendations for corrective actions with inputreview from Director Quality Management. Assists with follow-up on sponsor and internal audit queries. Including assisting with the writing of Corrective and Preventive Actions CAPA when applicable. Escalates and presents major findings to the Director of Quality Management. Identifies needed training programs for clinical research staff based upon quality assurance review and reports. Including but not limited to ALCOA source documentation completion and overall Quality Assurance process training. Responsible for Quality Management and preparation of study-related material for FDA EMA and Sponsor audits with assistance as necessary. When applicable participates in pre-study meetings as QA representative Evaluate and presents Quality Assurance findingsmetrics to appropriate staff members and managers. Performs other duties as assigned. Annual Salary Range 55180 - 89670 The University of Alabama at Birmingham UAB ONeal Comprehensive Cancer Center is seeking a Clinical Research Regulatory Coordinator III. This position will report to the Director of Quality Management and will be responsible for the review of data from clinical trial initiation throughout the trials duration. Will assist in assuring compliance with the ONeal Comprehensive Cancer Center standards and all applicable regulations with a strong emphasis on regulatory compliance. The Quality Management department is responsible for reviewing study data medical records case report forms monitoring letters drug accountability and regulatory files. It oversees Quality Assurance compliance with study protocols and ensures study guidelines are followed in accordance with Good Clinical Practices. Emphasis on regulatory documents. The ONeal 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 ONeal Cancer Center is a significant part of our economic powerhouse. The ONeal Cancer Center powers more than 400 scientists and physician-scientists cares for 20000 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 httpswww.uab.eduonealcancercenter Please attach a current resume with this application. General Responsibilities To prepare and submit multiple levels of research documentation i.e. IRB submissions educational materials reports grant renewal reports and study forms. To prepares and maintain FDA applications for Investigational New Drugs INDs and Investigational Device Exemptions IDEs. To lead the implementation of study specific regulatory processes of a moderate to complex nature. To conduct internal quality assurance audits of regulatory files as well as programs reports and teams working within clinical trial operations. To design and implement quality initiatives ensuring effective and efficient clinical processes. Key Duties & Responsibilities Audits Investigator Initiated Trials IIT Cooperative trials and pharmaceutical-sponsored trials. Conducts internal quality assurance audits of regulatory files. Assists in the design and implementation of quality initiatives ensuring effective and efficient clinical processes. Verifies compliance with protocols Standard Operating Procedures SOPs FDA ICH and GCP regulations. Maintains Quality Assurance data files. Prepares accurate audit reports makes recommendations for corrective actions with inputreview from Director Quality Management. Assists with follow-up on sponsor and internal audit queries. Including assisting with the writing of Corrective and Preventive Actions CAPA when applicable. Escalates and presents major findings to the Director of Quality Management. Identifies needed training programs for clinical research staff based upon quality assurance review and reports. Including but not limited to ALCOA source documentation completion and overall Quality Assurance process training. Responsible for Quality Management and preparation of study-related material for FDA EMA and Sponsor audits with assistance as necessary. When applicable participates in pre-study meetings as QA representative Evaluate and presents Quality Assurance findingsmetrics to appropriate staff members and managers. Performs other duties as assigned. Annual Salary Range 55180 - 89670 Bachelors degree in a related field and five 5 years of related experience required. Work experience may NOT substitute for education requirement. Certified Clinical Research Coordinator CCRC or Certified Clinical Research Professional CCRP certification preferred. Preferences Knowledge of ICH-GCP guidelines. Accuracy thoroughness and attention to detail are imperative. Skilled in maintainingreviewing records. Skilled in developing and maintaining effective working relationships with staff. Ability to work independently as well as within a team. Ability to communicate effectively with peers physicians and management both orally and in written form. Must be self-directedself-motivated. Skill in time management and executing workload with minimal supervision. UAB is an Equal EmploymentEqual 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 veterans 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 UABs Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edutitleix. Bachelors degree in a related field and five 5 years of related experience required. Work experience may NOT substitute for education requirement. Certified Clinical Research Coordinator CCRC or Certified Clinical Research Professional CCRP certification preferred. Preferences Knowledge of ICH-GCP guidelines. Accuracy thoroughness and attention to detail are imperative. Skilled in maintainingreviewing records. Skilled in developing and maintaining effective working relationships with staff. Ability to work independently as well as within a team. Ability to communicate effectively with peers physicians and management both orally and in written form. Must be self-directedself-motivated. Skill in time management and executing workload with minimal supervision. UAB is an Equal EmploymentEqual 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 veterans 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 UABs Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edutitleix.