Clinical Trials Research Project Manager

Kaiser Permanente   •  

Pasadena, CA

Industry: Healthcare


5 - 7 years

Posted 115 days ago

This job is no longer available.

Clinical Trials Research Project Manager

Description: Manages research support staff for clinical trials. Accountable for complex planning to coordinate support to large physician network. Implements high visible projects. Works independently in accordance with established objectives.

Essential Functions:

  • Develops department plans which identify key issues, problems, approaches, performance metrics and resources required.
  • Assists in development of different tools (e.g. tracking forms, regulatory review forms, etc.).
  • Monitors progress of study submissions and eligibility reviews activities (e.g. IRB applications, protocol eligibility, recruitment, etc.) and ensures that reports are submitted in a timely manner.
  • Contributes to high level discussions and acts as liason, problem solver, and facilitator between management, Sponsor, Contract Research Organizations (CRO), and research site.
  • Prepares progress reports independently and/ or collaboratively.
  • Actively participates in the training of new team members and/or clinical staff.
  • Ensures that all staff requirements and certifications are complete and current.
  • Identifies staff training needs and resources to address needs.
  • Develops and executes training plans.
  • Works with Sponsors/monitors during study start up and when they conduct monitoring visits.
  • Adheres to compliance and privacy/confidentiality requirements and standards.
  • Adheres to GCP and compliance regulations for clinical trials.
  • Oversees IRB submissions and reviews processes to ensure they remain current.
  • Makes recommendations for process improvements and/or enhancements.
  • Implements quality control and quality assurance measures when needed.
  • Acquires and maintains knowledge of KP systems and databases.
  • Makes decisions for day-to-day operations of projects including the resolution of technical problems and questions from project staff.
  • Collaborates with Clinical Trials Operations Manager and medical center staff to facilitate Program operations.
  • Negotiates and manages time commitments and resources.
  • Interfaces with IRB and drafts IRB new applications, amendments, continuing reviews, etc as necessary.
  • Supervises and manages the day-to-day activities of research support staff including evaluating performance and conducting regular and annual performance meetings.
  • Mentors, develops and trains staff.
  • Conducts hiring and disciplinary actions in partnership with the Clinical Trains Operations Manager.
  • Provides consultation to investigators and clinic coordinators on staff-related concerns.
  • May provide leadership and direction to multidisciplinary project teams.
  • Serves as a member and may provide leadership on department or study-related committees.
  • Prepares and oversees project budgets.
  • Seeks to develop cost effective ways to manage own resources.
  • Manages all aspects of clinical trial research studies in assigned medical center coverage area(s).

Basic Qualifications:

  • Minimum five (5) experience in a clinical research setting.
  • Minimum three (3) years of research project management experience.
  • Bachelor's degree.
    License, Certification, Registration
  • N/A.

    Additional Requirements:
  • Ability and/or experience in developing and implementing research tools.
  • Ability and/or experience developing and presenting professional reports and presentations to senior-level audiences.
  • Abilitiy and/or experience managing budgets, preferably research project budgets.
  • Direct personnel management experience.
  • Must be able to work in a Labor/Management Partnership environment.

Job Number: 716253