Pay Range Minimum
Job Code:
SF71
Hourly:
$25.1
FLSA*:
Exempt
Monthly:
$4,350
Grade:
232
Annually:
$52,200

*This is an Exempt position. Employees in this position are paid a salary on a monthly basis and are not eligible to receive overtime pay.

JOB DESCRIPTION: The Protocol Registration Analyst in the Winship Cancer Institute (WCI) will utilize their knowledge to administer the Protocol Review and Monitoring System for the Clinical Trials Office (CTO). Duties include: * Manages the PRC inbox and all correspondences with PIs regarding protocol approvals, amendments, and stipulations. Executes decisions regarding expedited approval and studies needing administrative approval. * Tracks low accruing trials and is responsible for knowledge regarding trial accrual history and presenting these findings to the Protocol Registry Management Committee (PRMC). * Oversees all PRMC and Working Group meetings, documentation of reviewer comments, distributes decision emails, and monitor the progression of trials in need of revision. * Works directly with faculty and staff to ensure protocol submission quality and accuracy. * Performs quality assurance/quality control reviews of clinical trial results submissions for consistency with review criteria. * Devises and implements strategies to improve the quality of submissions. * Develops and manages protocol registration timelines. * Provides clinical research team (physician- investigators, clinical research staff, nurses, etc.) protocol management support for initial submissions, tracks and captures protocol statuses throughout their lifecycle, and reports trial activity to multiple oversight authorities (institutional leadership, IRB, NCI, Clinicaltrials.gov). * Leads continuous quality control checks to identify missing data or inconsistencies across multiple databases. * Builds systems and processes to facilitate protocol data quality control and management. * Executes data reporting functionality to provide federal organizations and institutional stakeholders with relevant data associated with Cancer Center Support Grant (CCSG) standards. * Researches and analyzes problems and takes a leadership role in resolving. Serves as a project liaison to other teams, departments, the IRB, outside organizations and government agencies. * Provides ongoing monitoring and analysis of federal guidelines to ensure compliance. Creates and implements processes to ensure regulations are met; i.e. checklists and workflows with other departmental study teams. * Develops and maintains internal work instructions, tools/materials, and documentation for this position. * Actively participates in designated committees within the unit and Emory University. * Assists in the preparation of tables, graphs, and reports for publication and presentation. Performs related responsibilities as required.
MINIMUM QUALIFICATIONS: Bachelor's degree in a related field and one year of research experience OR an equivalent combination of experience, education, and training. PREFERRED QUALIFICATIONS: Knowledge of IRB processes, federal research regulations and a basic understanding of funding programs, clinical research practices and clinical trials development/implementation

The above statements are intended to describe the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the personnel so classified.

EQUAL EMPLOYMENT OPPORTUNITY / AFFIRMATIVE ACTION EMPLOYER:

Emory University is dedicated to providing equal opportunities to all individuals regardless of race, color, religion, ethnic or national origin, gender, age, disability, sexual orientation, gender identity, gender expression, veteran's status, or any other factor that is a prohibited consideration under applicable law.

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