Clinical Trials Research Project Manager Pasadena, CA
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.
- 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).
- Minimum five (5) experience in a clinical research setting.
- Minimum three (3) years of research project management experience.
- Bachelor's degree.
License, Certification, Registration
- 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.
- Master's degree, preferably in public health, healthcare administration, epidemiology, or related field.
Primary Location: California,Pasadena,S. Los Robles Administration 100 S. Los Robles
Scheduled Hours (1-40): 40
Working Days: Mon, Tue, Wed, Thu, Fri
Job Type: Standard
Employee Status: Regular
Employee Group: Salaried, Non-Union, Exempt
Job Level: Entry Level
Job: Research and Development
Public Department Name: Clinical Trials
External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, protected veteran, or disability status.
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