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.
- 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.
Job Number: 716253