Director, Research Operations (DCR)

The Director of Clinical Operations is responsible for the management of the Phase I clinical research business, consistent with company principles, strategies, and objectives. This position is accountable for the overall coordination, organization, and efficient implementation of clinical trials and regulatory compliance. This position reports to the Sr. Director, Clinical Operations or the VP, Clinical Operations depending on location.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Performs full supervision of recruitment, hiring, retention, performance development, performance management, teammate relations, salary adjustments, and termination of direct reports

• Performs diverse managerial responsibilities requiring considerable analysis, judgment, and detailed understanding of the clinical research process

• Works closely with the Medical Director to evaluate clinical trials and ensure that all study-related procedures are completed properly from a clinical, safety and regulatory perspective

• Ensures all activities adhere to Good Clinical Practice (GCP), International Committee on Harmonization (ICH) guidelines, company standard operating procedures, and any applicable federal, state and local regulations

• Coordinates the provision of needed support services

• Works with Sr. Director or VP to ensure the financial performance of the Early Clinical business

• Works with the Medical Director and operational team(s) to determine which clinical studies to pursue

• Provide direct supervision and work direction for department teammates

• Determine staffing plans that promote the most effective use of all teammates; ensure coverage during teammate absences

• Assist in the development and maintenance of teammate training, reference and audit tools

• Knows, understands, implements, follows, and communicates to teammates all DaVita employment policies and procedures, awards, and other opportunities within company and foster a positive work environment

• Facilitates teammate development (PDRs, coaching, mentoring, DaVita training, outside training); collaborates with direct reports to create professional development goals

• Maintains familiarity with and communicates to teammates DaVita programs impacting teammates

• Reviews/Approves timecards as needed, tracking PTO and overtime

• Addresses teammate relations issues appropriately and escalate as necessary

• Develops and conducts educational programs to keep teammates up-to-date on DaVita policies, new laws and regulations impacting work, and other information necessary to maintain teammates’ knowledge of department processes and goals

MINIMUM QUALIFICATIONS

• Minimum BS/BA or equivalent experience in Clinical Research.

• Minimum 5 years of Clinical Research Experience or equivalent experience

• Minimum 2 years of direct management experience

• Minimum 2 years of Phase 1 experience preferred

• Commitment to and role model of DaVita’s values with ability to demonstrate those positively and proactively to patients, teammates, management, physicians, and/or vendors (Village Service Partners) in everyday performance and interactions

• Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately in an evolving work environment with shifting time frames; self-starter with high degree of initiative, urgency, and follow through.

• Innovative, analytical thinker with demonstrated ability to perform root cause analysis, prepare and implement action plans, and lead improvement initiatives

• Demonstrated ability to create, refine, and manage new business processes

• Travel required, less than 10%.

• Evening/night/weekend work required, as need to fulfill job duties.

• Deals with confidential information and/or issues using discretion and judgment.