Careers

SECTION III:  PRIMARY JOB RESPONSIBILITIES AND ACCOUNTABILITIES:  (Please list no more than 10 primary job responsibilities).  The primary job responsibilities and accountabilities listed below represent work performed by this position and are not all-inclusive. The omission of a specific accountability will not preclude it from the position if the work is similar, related, or a logical extension of the position. 

Work closely with investigators to oversee compliance with protocols including consent/assent procedures; adverse event detection and reporting; appropriate eligibility screening; and proper and timely protocol implementation and study initiation. 

Provide expertise and council to investigators and other stakeholders to organize and lead the development, implementation and assessment of the department’s research program. Actively participate in leading departmental research and team meetings; creating and reviewing research standard operating procedures (SOPs); and by representing research staff in SRI meetings and activities.

Lead departmental efforts of clinical and research integration. Work with clinical and research staff in the creation of processes for reducing time waste in clinic during research procedures.  Develops Lean strategies to increase research productivity and lower the costs.  

Acknowledge and manage competing interests and broader needs of the organization.  Understand and address complexities of cost and outcome measures for cross-functional, multi-disciplinary and inter-departmental activities.  Ensure most effective, efficient use of operating, capital and human resources to best meet current and anticipated demand for services.

Continually assess operational objectives, organizational structures and work processes to assure optimum skill mix, scheduling and staffing levels to meet standard work,  project needs and external events.   Implement Lean principles and consistent performance management practices by defining and communicating goals and performance objectives; by leading huddles and regularly monitoring, evaluating and improving individual and team performance.  Provide coaching and mentoring and other training and development activities to build staff competencies.  Develop and implement evaluation criteria that define highly competent, high-performing individuals and teams.

Collaborate with investigator to provide leadership, council and assistance in implementing, managing and sustaining research protocols.  Ensure compliance with initial and on-going compliance with professional, institutional, regulatory, budgetary, contractual, and other regulations, requirements and accepted clinical practices.  Develop, implement, and maintain processes, practices, protocols and procedures to ensure the timely and accurate submission of IRB applications, renewals, and correspondence.

Contribute to publications and presentations of the faculty, including participation in grant conceptualization and grant writing. Perform data analysis and data collection. Contribute to the writing of research proposals, articles, scientific summaries and reports:

- Follow standard research writing style and formats to translate clinical research data into coherent and insightful description of procedures and results; ensure results are published in peer-reviewed journals

- Assist in the creation of poster boards for presentations.

Actively participate in the development of new funding applications and progress reports for submission to extramural agencies, including data collection and writing assistance.  Develop system for evaluation of faculty research proposals, including clinical standard work pathways and alocate CRA time accordingly. 

Maintain high level of professional expertise and familiarity with current scientific literature:

- Attend and present at national and local research conferences/ workshops/meetings and other pertinent educational opportunities.

- Attend and participate in research events at Seattle Children’s; actively participate in institutional continuing education offerings and seek out new CE opportunities.

- Keep abreast of literature related to clinical research in general and specific to clinical area; share information with research team.

Supervise and serve as a resource for the education/training of MDs and supervise and mentor research staff, udenrgradute and graduate students, residents and fellows.  Assign weekly tasks and oversee work.  Maintain productivity and efficiency of research staff.

SECTION II:  QUALIFICATIONS

The minimum qualifications listed below (along with education/experience) are representative of the knowledge, skills, and abilities needed to perform this job successfully.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties and responsibilities of this position.

Minimum Education and Experience:  (Identify only education requirements that are legally defensible – e.g., an attorney needs a Juris Doctor)

Required Education/Experience:

- Master’s degree in scientific, medical specialty or equivalent

- Experience in a clinical study data environment to include experience with randomized clinical trials, participation in multicenter studies and registries, observational studies utilizing electronic data capture, and other data capture systems

- Supervisory experience/skills.

Required Credentials:

N/A

Preferred:

- PhD or advanced degree in scientific, medical specialty or equivalent.

- Experience leading data management process development and quality assurance efforts including development and implementation of standard operating procedures.

- Experience with clinical trial management systems (CTMS) and other databases including REDCap

-- Able to lead, guide, coordinate and facilitate strategic planning processes.

- Succesful grant writing efforts

- Experience using continuous process improvement (CPI) methodologies.