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Clinical Trials Coordinator and Clinic Manager

Job #19.04.6001.01 Category: Clinical ResearchLocation: Parkinson's Institute
Job Description:

Summary:

Manages clinical trials and ensures high quality regulatory and service standards. Oversees and manages clinical research coordinators. Monitors performance of the clinic on a regular basis, making any necessary operation changes as may be required.  Provides leadership and direction to clinic staff and helps resolve issues that may develop between physicians and administrative staff.  The Clinical Trails Coordinator/Clinic Manager is a team-oriented individual with clinical research and management experience, the ability to interact in a multidisciplinary environment, and demonstrated coaching skills.

Position Responsibilities: 

Clinical Trials Coordination Responsibilities:

  • Manage clinical research coordinators.
  • Ensure regulatory affairs documents are accurately prepared and in compliance with sponsor/IRB guidelines and instructions.
  • Ensure all clinical trials study activities are completed and conducted per sponsor protocol and good clinical practices.
  • Oversee subject recruitment and scheduling and ensure study visit assessments are in compliance with protocol guidelines.
  • Maintain communication and documentation between study subjects, clinical trials personnel, and study investigators.
  • Maintain accurate source documents, logs, case report forms, laboratory results, and video data collection for all clinical trials.
  • Lead external communication with sponsors, outside partners, FDA, and patients.

Clinic Management Responsibilities:

  • Manage and oversee the daily flow of clinic operations and personnel to ensure maximum efficiency.
  • Develop, maintain, and update the policies and procedures for clinic management.
  • Collect and report clinic productivity metrics.

Other Responsibilities

  • Working with the Medical Director, ensure all staff have performance development plans, which include feedback for development and established goals and objectives for the evaluation period.
  • Assist HR with recruiting, coaching, and encouraging continual learning.
  • Develop and implement programs/process that encourage teamwork.
  • Assist clinic staff with problem resolution.

Job Requirements:

Qualifications:

Essential

  • BS degree and 8+ years’ experience in outpatient and clinic operations (preference for 3 years + in Clinical Research experience). RN is helpful but not required.
  • Strong attention to detail.
  • Excellent communication skills - clear and concise verbal and written skills.
  • Ability to influence change with a positive outcome.
  • Flexibility (must be able to switch between personally rooming a patient, supervising staff, and strategizing operational issues).
  • Computer savvy (preference for EDC experience).
  • Self-starter.
  • Enjoys working as part of a team.
  • Please note, although this is an exempt level M-F 8:30-5:00 position, this position may require some Saturday work. Remote work is not available given the nature of the studies.
  • Must be local to SF Bay Area or reasonable driving distance. No relocation budget available.

    Desired
  • Previous experience in managing clinical trials is a plus.
  • Certificate in clinical trials preferred (SOCRA - ACRP)
  • Familiarity with clinical trial terminology is preferred.
  • California certified phlebotomist or active RN helpful

Work Environment

Office work environment

Medical clinic setting which includes daily interaction with clinic administrative staff, clinic medical staff, patients/care givers, co-workers in other departments as well as desk type or work.  The pace is fast, yet efficient.

Must carry/lift loads of:  25-50 lbs.


Benefits:
Medical Dental  Vision  Life  EAP  Commuter  403(b) and more...

 

Click here to apply:

http://www.indeed.com/job/clinical-trials-coordinator-and-clinic-manager-d6cbee7cf7971270


2500 Hospital Drive, Bldg #10, Suite 1 | Mountain View, CA 94040
650.770.0201 main | 650.770.0204 fax (Clinic Secure)