Job description

Duties: Reporting directly to the Data and Safety Monitoring Committee (DSMC) Manager within the Abramson Cancer Center and indirectly to the Chief ACC Compliance Officer- Clinical Research, the Data and Safety Monitoring Committee (DSMC) Coordinator is responsible for assisting the DSMC Manager with all aspect of coordination of the DSMC monthly and ad hoc meetings. This includes sending quality, compliance and safety queries to investigator and following the queries through to conclusion; researching pharmacovigilance issues in medical records and corresponding regulations to determine compliance with regulations for appropriate safety case studies; providing reports to the DSMC manager; reviewing Quality Control and Assurance issues identified by the Manager of Regulatory Compliance and taking appropriate corrective actions as defined by the DSMC and collecting metrics to be reporting to the DSMC and CCO-CR. Ensuring DSMC activities comply with all NCI expectations, tracking data in proprietary systems and reporting as necessary; prepares meeting agendas; attends convened meetings; and maintains thorough and complete notes on the discussion. He/she prepares complete accurate minutes of the meeting including attendance, actions taken, the vote on these actions, the basis for requiring changes in research, and a written summary of controverted issues and their resolution. The DSM C Coordinator prepares written correspondence to investigators of applicable DSMC actions and decisions. The DSMC Coordinator reviews and records exceptions, deviations, and independent safety reviews; maintains minutes, DSMC rosters, DSMC electronic files and all other required regulatory documents in compliance with federal regulations, institutional policies, and ACC SOPs. The DSMC Coordinator provides guidance on issues related to DSMC regulations and actions. The DSMC Coordinator participates, as assigned, in research community outreach and training activities; as well as DSMC member training and DSMC quality improvement initiatives including the review of existing DSMC policies and procedures. The DSMC Coordinator is responsible for maintaining a database of information related to DSMC activities and generating reports that are used by ACC leadership and the NCI.

Qualifications: Minimum of a BA/BS in a relevant discipline (biological sciences required) and 3-5 years of experience and knowledge directly related to clinical research or an equivalent combination of education and experience required; detailed knowledge of applicable regulations related to clinical research. Knowledge of the purpose, function and operations of a Data and Safety Monitoring Board is a strong plus. Demonstrated project and time management skills are necessary; must be able to work independently with minimal supervision. Outstanding organizational skills and the ability to function in a team environment are required. Qualified candidates must also demonstrate excellent written and verbal communication skills; advanced computer software skills; a clear attitude of customer service; must be able to work in a fast-paced environment with time sensitive deadlines and competing priorities; the ideal candidate will have very strong analytical and critical thinking skills, and the ability to build and maintain positive working relationships at all levels of the institution.

This job description is not intended to contain or be interpreted as a comprehensive inventory of all duties and responsibilities required of employees assigned to the job.

Reference Number: 40-30323

Salary Grade: 026

Employment Type: Exempt

Org: CC-Cancer Center

Special Requirements:

Job Family: A-General/Professional Administrative




Diversity Profile: University



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Job No:
Posted: 11/8/2018
Application Due: 1/10/2019
Work Type: