Memorial Sloan Kettering Cancer Center
New York City, NY, United States
Clinical Research, Pharmaceutical, Research, Audit, Healthcare
At Memorial Sloan Kettering (MSK), we\u2019re not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we\u2019re driving excellence and improving outcomes. For the 28th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker\u2019s Healthcare list as one of the 150 Great Places to Work in Healthcare in 2018, as well as one of Glassdoor\u2019s Employees\u2019 Choice Best Place to Work for 2018. We\u2019re treating cancer, one patient at a time. Join us and make a difference every day.
We are seeking a Clinical Research Audit Specialist to join our Clinical Research Audit Team.
Actively participate in and support the daily operations of MSK\u2019s centralized clinical research audit program.
Conduct all types of audits (protocol compliance, CR financial, CR database systems), as dictated by QA Leadership.
Perform a required number of audits each quarter, supporting team members with audits as needed.
Support data management needs of the CR Audit Team including but not limited to Audit Metrics, Operational Reports and analytics.
Report directly to a Senior CR Auditor.
Bachelor\u2019s degree with at least 3 years of clinical research experience.
Human Subjects Protection Certification, GCP Certification, GMP Knowledge, FDA/EMA requirements, Quality Standards and Systems experience.
Communication Skills: The ability to develop, facilitate, and orchestrate effective communication with all members of MSK; responsible for the writing, preparing and educating staff on clinical research procedures and processes. You will communicate with all levels of staff including clinical staff (investigators, nurses etc), administration, research and clerical support staff, and Institutional Leaders as well as external sponsors. Excellent oral and written communication skills are essential.
Federal Regulations: Must have an advanced comprehensive knowledge and understanding of the regulations pertaining to human research protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations) and Health Insurance Portability and Accountability Act (HIPAA).
Information Management Skills: The ability to communicate, explain, interpret, share and present information to employees, management and clinical staff and patients at MSK as well as appropriate external contacts.
Analytical Skills: A strong ability and understanding on how to collect, analyze, interpret and prepare data for presentation (i.e., written, tabular and graphical formats). Excellent problem-solving ability. Ability to analyze situations, draw conclusions, make recommendations and convey information in a timely and proficient manner. Strategic thinker.
Time Management Skills: The ability to set priorities among several tasks simultaneously and meet established deadlines. Ability to manage multiple large-scale development projects simultaneously. Ability to guide staff to ensure programmatic activities adhere to established time frames and deadlines.
Administrative Skills: The ability to plan, organize, facilitate and lead meetings, to develop programs, to manage research projects and to prioritize work across several services/departments is essential.
Computer Skills: Proficiency in use of computers and software such as database management, spreadsheet, word processing and graphics applications. Knowledge of mainframe systems utilized at MSK is important.
MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.
Memorial Sloan Kettering Cancer Center
Website : http://www.mskcc.org