Job

Clinical Operations Manager - University of Washington

Description:

The Collaborative Health Studies Coordinating Center (CHSCC) is a non-profit, academic organization with over 20 years of experience running multi-site epidemiologic studies and clinical trials. Our center is a collaborative effort involving faculty, staff, and students from the Departments of Biostatistics and Epidemiology at the University of Washington. Our team of programmers, biostatisticians, epidemiologists, and project managers provides expertise in study design, data collection and management, and statistical analysis. Our mission is to support studies that further scientific inquiry in areas that will ultimately impact public health. We also support the next generation of researchers by offering assistantships to current students and postdoctoral fellowships to recent graduates.

The CHSCC seeks a full-time Clinical Operations Manager for the Multi-Ethnic Study of Atherosclerosis Data Coordinating Center, an NHLBI-funded study of cardiovascular disease that started in 2000.  Under the direction of the Project Director and MESA investigators across the US, the Clinical Operations Manager will design and implement a 7th clinical exam and be the primary liaison with clinical sites for all clinical operations issues including protocol implementation, data collection, data quality, and training and certification of clinic staff.

This position requires a high level of autonomy and the ability to make decisions at the management level.  It requires planning and synthesizing research activities and directing the work of programmers and research coordinators, careful attention to detail and accuracy, understanding of research protocols, and strong organization skills. As the point of contact for a large number of field centers, this position requires strong communication and time management skills and the ability to juggling multiple competing priorities.     

This research position is key to the success of the MESA study, a multi-cohort study in its 20th year of operation that has contributed over 1,500 scientific publications to date. The CHSCC in the Department of Biostatistics is high visibility in the research community at both the local and national levels and enjoys an excellent reputation as an outstanding center for research design and biostatistical analysis.  The high quality of the CHSCC’s work helps to enhance the University’s research environment and in turn, helps to attract funding for further research studies.  This active research environment attracts world-class faculty and students to the University and provides excellent training opportunities for students.

Job Duties

1. Triage problems/questions from clinics – forward issues to other staff when necessary. Serve as the main contact at Coordinating Center for all protocol and clinical operations questions, as well as software questions 
2. Track certification and certification maintenance of clinical personnel. Follow-up with Field Center staff as needed 
3. Develop and maintain all data collection forms and manuals of operations in conjunction with Project Director(s) and Principal Investigators 
4. Assist with conducting regular field center staff conference calls. Develop material to present during these calls.   Participate in standing study committees, including assistance with scheduling and minutes. 
5. Collaborate with programming staff on software updates, testing, and bug-corrections 
6. Coordinate, set up and conduct training of field center personnel, includes central training and any re-training necessary during data collection 
7. Design and oversee production and distribution of participant results letter and alert communications
8. Collaborate with Principal Investigators on clinical procedures for laboratory specimen collection and communication with laboratories 
9. Assist the Project Director in the design of quality assurance systems and on-line reports
10. Ensure Data Coordinating Center and clinic compliance with all regulations, including proper consent forms and IRB approvals 
11. Coordinate and conduct an evaluation of clinical performance and adherence to protocol during clinical site visits (as necessary) 

Required Experience:

• Managing clinical operations activities for human-subjects research 
• Proven success working with a collaborative research team    
• Meticulous organizational skills and proven ability to multi-task and work independently and effectively in large, complex, multi-site, cross-functional teams
• Demonstrated problem-solving ability and attention to detail while working in a fast-paced, deadline-driven environment    
• Excellent work ethic and self-motivation.
• Management of Human Subjects/IRB issues and procedures. 
• Data management and analysis using statistical software (SPSS, R, STATA, SAS)  
• Strong verbal and written communication skills with the ability to manage relationships and interact with a wide range of researchers and clinic staff.
• Willing to travel for site training and/or study meetings
   

Desired Experience:

• Experience working with an sIRB on a multi-center research project     
• Previous experience in the administration and coordination of a large epidemiological cohort study     
• Ability to use REDCap to design, conduct, and/or monitor data collection    
• Cardiovascular Disease Epidemiology Research
   

 

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