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Medical Director of Clinical Research

California Institute for Renal Research


Location:
San Diego, California 92123
Date:
07/13/2017
2017-07-132017-08-12
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Clinical Operations
  • Medical Doctors
California Institute for Renal Research
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Job Details

Medical Director of Clinical Research

Overview

The California Institute of Renal Research (CIRR) was founded in 2000, and is a wholly owned subsidiary of Balboa Nephrology Medical Group. CIRR has earned an excellent reputation for conducting studies in the specialty areas of CKD (chronic kidney disease), dialysis, vascular access, and renal transplantation.  Due to its close working relationship with Balboa Nephrology Medical Group Inc., CIRR has access to over 45 nephrologists, a large transplant program, and over 4,000 dialysis patients. This relationship, along with its principal investigators, staff, and research facilities, has made CIRR an established presence throughout San Diego and Imperial Counties

Our principal investigators work closely with our twenty full- time clinical research staff and our Manager of Clinical Research Operations. Since 2000, CIRR has participated in over 150 studies, enhancing its reputation as an outstanding research organization for Phase 1 to Phase 4 studies.

As CIRR continues to grow, we are looking for a high performing, energetic physician to be our dedicated Medical Director of Clinical Research to lead our team.

 

Summary:

This role will provide clinical leadership and oversight of clinical trials ensuring the trials are conducted to the highest quality standards, meeting enrollment goals and timelines. 

Research Responsibilities include:

  • The execution of clinical trials from Site Initiation to Close Out.
  • Budget and contract execution.
  • Participation in the data cleaning, ongoing medical review, data interpretation and reporting of the results of the research, including submission to health authorities.
  • Acting as the key physician contact for sites and investigators during site start-up and study execution.
  • Developing and applying best practices in the initiation, planning, execution, control and closing of trials.
  • Acting as a liaison between the company and the clinical investigators.
  • Evaluating scientific information and new ideas to assist in identifying new research opportunities.
  • Ensuring the physicians and staff within the practice are fully informed of trials and their criteria and are able to contribute as required to enrollment for the studies.
  • Liaise with CROs, sponsors and dialysis facilities to ensure successful execution of trials.
  • Coordinating efforts for the trials using internal clinical operations resources.
  • Ensuring clinical activities are run in accordance with internal SOPs, FDA/ICH/GCP guidelines and/or local regulations.
  • Liaise with the Clinical Operations Manager and Study Coordinators to make sure appropriate corrective and preventative actions are put in place after audits of internal systems and investigator sites.
  • Developing and maintaining excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators.
  • Working effectively in a team setting and reporting to the CEO, BNMG.

Clinical Responsibilities include:

If interested, clinical duties to include call coverage and dialysis rounding, as time permits.

Requirements

Requirements:

  • Must be a M.D. or D.O.
  • The role requires a high performing and energetic individual who demonstrates outstanding scientific knowledge, applicable to nephrology clinical research and the highest and personal ethical standard.
  • Applicable post-doctoral fellowship training in Nephrology is required.
  • A minimum of 2 years of experience in clinical research preferably in nephrology.
  • A good understanding of the pharmaceutical clinical development process. Must have a good working knowledge of clinical operations, clinical processes and CROs.
  • Highest scientific and personal standards and ethics.
  • Knowledge of applicable U.S. regulations and guidelines.
  • Ability to lead, direct and develop others.
  • Advanced ability to successfully manage a full workload across multiple-projects.
  • Excellent oral, written communication and presentation skills are required.

We offer a comprehensive benefit package that includes medical, dental, vision and retirement benefits. Background check required. 

For consideration please apply at www.bnmg.org. Under the “About” tab, select “Jobs” to be redirected to our application website. A cover letter and resume including salary requirements is required.

NO PHONE CALLS PLEASE

BNMG is an EOE.