Chief Operating Officer

Position Number: COO.0916 - download pdf

Cancer Research And Biostatistics (CRAB) is a non-profit organization whose purpose is to help conquer cancer and other diseases through the application of biostatistical principles and data management methods.

Position Summary:

The Chief Operating Officer (COO) is responsible for the oversight, management and coordination of clinical trial operations for the successful implementation of therapeutic and prevention trials within the SWOG cooperative group and CRAB Clinical Research Services (CRS). The COO promotes the coordination and engagement between CRAB, the SWOG Statistical and Data Management Center (SDMC), the SWOG Operations Office and the SWOG Group Chair’s Office. This position assures that activities are aligned with the CRAB mission and in compliance and observance of all quality and regulatory policies and procedures.  In addition to general operating responsibility, the COO is a member of the Officer executive team and is responsible for effective coordination and collaboration with other members of this team. This position participates in major policy development and strategic planning, and represents the organization in external meetings. The COO will manage and is accountable for the overall performance of clinical operations across departments to ensure that operational goals are met. The COO reports directly to the Chief Executive Officer (CEO).

Duties and Responsibilities:

  • Provide oversight and guidance across the organization for priority projects, and ensure that the CEO receives proper and timely information.  Communicate program/project status and relevant information between officers, management, departments, employees, and stakeholders
  • Lead the CRAB clinical trial operations by successfully developing and executing growth strategies, and oversee the clinical trial and monitoring processes for both SWOG and CRS projects.  Develop and implement strategies to consistently provide outstanding services to clients
  • Oversee the preparation and execution of acquired projects, and monitor the progress of projects against their contract timelines, deliverables, and budgets
  • Continuously monitor program operations; develop and implement corrective action plans as needed within projected time frames.  Meet all required work deadlines and ensure that all applicable staff receive the necessary information to complete their job duties
  • Promote coordination and engagement between CRAB, the SDMC, the National Cancer Institute (NCI), the SWOG Operations Office and the SWOG Group Chair’s Office
  • Collaborate with the Chief Technology Officer (CTO) to plan, develop, implement and direct projects/programs aligned with the CRAB mission and in compliance and observance of all quality and regulatory policies and procedures
  • Collaborate with the Chief Business Development Officer (CBDO) on business development across clinical trial operations, be responsible for effort estimates and statements of work supporting bids and proposals to potential clients, review bids and proposals, and represent the company for bid defense
  • Collaborate with the Chief Financial Officer (CFO) and Grants and Contracts Manager to oversee budget development for government programs, assuring they are contractually responsive and otherwise accountable
  • Coordinate with the Officer executive team and other stakeholders to identify and resolve compliance-related issues
  • Oversee the validity of data and ensure compliance with Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP). Work with the Regulatory Affairs/Quality Assurance (RA/QA) Manager on quality and regulatory issues. Interface with CRAB management regarding data security, compliance and quality initiatives.  Responsible for departmental inspection readiness, regulatory submissions and risk mitigation
  • Provide support and mentoring to staff regarding project management, data management, clinical monitoring, staffing and budgeting
  • Maintain awareness of developments in the clinical trials research arena
  • Provide recommendations and direction for design of data processing/data capture tools
  • Establish, support, and enforce company policies and procedures related to clinical trial operations
  • Prepare, review and present materials to the Board of Directors, potential and current clients, and regulatory agencies such as the Federal Drug Administration (FDA) and/or NCI
  • Work with the Officer executive team and other partners in implementing CRAB’s goals and objectives. Actively contribute to identify and solve problems
  • Demonstrate positive attitude, flexibility, and commitment to meeting the needs of all customers, both internal and external
  • Coordinate administrative services and functions, as needed, in collaboration with the Officer executive team
  • Advance the CRAB mission, values and goals, and ensure that reporting staff are aligned in their actions and responsibilities to contribute to this effort

Qualifications:

  • Advanced degree relevant to position
  • Minimum 10 years of experience in clinical research, life sciences, or federal research with at least 5 years in data management; or equivalent combination of education and experience
  • Minimum five years of proven general management, supervisory, and operational experience; or equivalent combination of education and experience
  • Proven leader with the ability to delegate responsibilities, motivate staff and encourage team building across the organization
  • Strong team leadership, management, and mentoring skills
  • In-depth knowledge of International Council on Harmonisation (ICH) guidelines and FDA guidance, compliance, and regulatory information
  • In-depth knowledge of medical and therapeutic areas including cancer medical terminology
  • Ability to travel up to 15%, national and international

Preferred Knowledge, Skills and Abilities:

  • Several years of experience in oncology clinical trials
  • Excellent judgment and decision making skills
  • Effective communication skills and comfortable working with diverse groups of individuals
  • Excellent interpersonal skills; must be able to effectively relate to personnel at all levels of the organization, promote interaction between teams and departments
  • Superior analytical, presentation, and problem solving abilities
  • Effective organizational and negotiation skills
  • Proficient Microsoft Office suite computer skills
  • Spanish language skills highly desirable

This position is full time and is Exempt from state and federal overtime regulations
Employment authorization is required.
CRAB is an Equal Opportunity Employer.

In your cover letter, describe how your skills and experience match the qualification for the position.

To apply, submit resume and cover letter with position number via U.S. Mail, FAX or email to:

Cancer Research And Biostatistics
Attn:  Hiring Coordinator
1730 Minor Avenue, Suite 1900
Seattle, WA  98101-1468
FAX:
(206) 342-1689
E-mail:


Posting Date: September 1, 2016            Closing Date: Open till filled