What are the responsibilities and job description for the MANAGER-CLINICAL RESEARCH REGULATIONS position at University of Alabama, Birmingham?
The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center is seeking a Manager-Clinical Research Regulations.
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: https://www.uab.edu/onealcancercenter/
Please attach a current resume with this application.
General Responsibilities
- To oversee regulatory team in larger organizations.
- To manage the preparation and submission of multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
- To lead the implementation of study specific regulatory processes of a moderate to complex nature.
- To maintain study s compliance with institutional requirements.
- To serve on various committees as appropriate.
Key Duties & Responsibilities
- Oversees OCCC Quality Assurance team. Assign duties to junior staff.
- Reviews participant study data/source binders/Informed Consents to ensure compliance with study protocols and related guidelines
- Verifies compliance with protocols, Standard Operating Procedures (SOPs), ICH and GCP.
- Ensures adherence to established regulations and guidelines.
- Audits data and reports for accuracy and compliance with protocol requirements, SOPs, and GCP regulations.
- Schedules and performs inspections and audits for assigned work and maintains QA data files.
- Prepares accurate audit reports and makes recommendations for corrective actions with input/review from Director Quality Management.
- When applicable, participates in pre-study meetings as QA representative.
- Assists with follow-up on sponsor and regulatory concerns. Implements QA processes.
- Responsible for Quality Management and preparation of study-related material for FDA and Sponsor audit with assistance as necessary.
- Ensures proper correction of any queries or issues noted in research data.
- 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 QA process training.
- Evaluates and presents QA findings/metrics to appropriate staff members and managers.
- Answers inquiries from operations staff when protocol or study-related questions arise. Escalates and presents major findings to the Director of Quality Management.
- Manages the preparation and submission of multiple levels of research documentation.
- Leads the implementation of study-specific regulatory processes of a moderate to complex nature.
- Maintains study's compliance with institutional requirements.
- Assists colleagues in identifying efficiencies and improving processes.
- Serves as a mentor to junior regulatory staff.
- Assigns, reviews, and trains others in various work responsibilities.
- Establishes and assigns the activities of subordinate personnel to accomplish study goals.
- Participates in relevant regional and national forums.
- Manages protocol-specific data into required institutional systems (IRAP, OnCore, etc.).
- Conducts internal quality assurance audits of regulatory files.
- Develops and oversees the implementation of Standard Operating Procedures (SOPs) when needed.
- Writes reports, business correspondence, and procedure manuals as needed.
- Plans, develops, and presents training.
- Provides human resources oversight for subordinate personnel
- Performs other duties as assigned.
Annual Salary Range: $77,640 - $126,170
- MSN preferred.
- Knowledge of ICH-GCP guidelines.
- Accuracy, thoroughness, and attention to detail are imperative.
- Skilled in maintaining/reviewing 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-directed/self-motivated.
- Skilled in time management and executing workload with minimal supervision.
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.
Salary : $77,640 - $126,170
