Job Description

2476 Swedesford RdSTE 150, Malvern, Pennsylvania, 19355-1456, United States of America

Manages the overall operations of the clinical research program on the West Coast that includes hiring, training and oversight of the research staff, ensuring that studies meet enrollment goals, and study data is completed accurately and on a timely basis. This position reports to the Director of Field Operations.

ESSENTIAL DUTIES & RESPONSIBILITIES

The following duties and responsibilities generally reflect the expectations of this position but are not intended to be all-inclusive.

* Manages operations at regional research sites with DCR employed study coordinators.
* Assists with Principle Investigator and Sub-Investigator selection for clinical trials.
* Assists with evaluating new protocols.
* Assists with designs of new forms/source documents tools to be used in protocol implementation.
* Works with physicians to promote appropriate principle investigator oversight
* Develops and Maintains relationships with Facility Administrators and direct care teammates as related to research operations.
* Oversees local site training and clinical study execution to ensure study conduct is within the guidelines set forth in Good Clinical Practice (GCP) and International Council for Harmonization (ICH).
* Coordinates with Quality Assurance to ensure teammates are trained on Standard Operating Procedures, research regulations and applicable healthcare regulations.
* Conducts Monthly study reviews with principle investigators.
* Oversees financial and study tracking in Clinical Conductor / CTMS
* Assists the Director of Field Operations in preparing monthly operational updates for senior leadership.
* Provides direct supervision and work direction for regional teammates
* Assists with determining 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 teamwork at the site and within the region
* Addresses teammate relations issues appropriately and escalate as necessary
* Oversees/ conducts potential and current sponsor and CRO visits.
* Develops and Maintains relationships with the pharmaceutical industry to promote placement of new studies at the regional sites.
* Performs additional duties as assigned.

MINIMUM QUALIFICATIONS

Education, licenses, certifications, and experience required to fulfill the essential duties, include computer skills as required.

* Minimum BS/BA prefer science area of study
* Minimum 5 years of Clinical Research Experience or equivalent experience
* Minimum 5 years of direct management experience
* Commitment to and role model of DaVitas 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 50%.
* Deals with confidential information and/or issues using discretion and judgment.

What Well Provide:

More than just pay, our DaVita Rewards package connects teammates to what matters most. Teammates are eligible to begin receiving benefits on the first day of the month following or coinciding with one month of continuous employment. Below are some of our benefit offerings.

* Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out
* Support for you and your family: Family resources, EAP counseling sessions, access Headspace, backup child and elder care, maternity/paternity leave and more
* Professional development programs: DaVita offers a variety of programs to help strong performers grow within their career and also offers on-demand virtual leadership and development courses through DaVitas online training platform StarLearning.