Research Project Manager, Oncology Clinical Trials
Primary Location San Diego, California
Worker Location Flexible
Facility Zion Medical Center
Job Number 1326071 Date posted 12/18/2024
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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.
Job Summary:
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 Responsibilities:
- 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:
Experience
- Minimum five (5) experience in a clinical research setting.
- Minimum three (3) years of research project management experience.
Education
- Bachelors degree in public health, healthcare administration, epidemiology, or health-related field (ex. Biology, Psychology, etc.), OR four (4) years of experience in a directly related field.
- High School Diploma or General Education Development (GED) required.
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.
Preferred Qualifications:
- Oncology Clinical Trials experience highly preferred
- Masters degree, preferably in public health, healthcare administration, epidemiology, or related field.
Primary Location: California,San Diego,Zion Medical Center
Scheduled Weekly Hours: 40
Shift: Day
Workdays: Mon - Fri
Working Hours Start: 08:00 AM
Working Hours End: 04:30 PM
Job Schedule: Full-time
Job Type: Standard
Worker Location: Flexible
Employee Status: Regular
Employee Group/Union Affiliation: NUE-SCAL-01|NUE|Non Union Employee
Job Level: Team Leader/Supervisor
Department: Department of Research and Evaluation
Pay Range: $109100 - $141130 / year
Kaiser Permanente strives to offer a market competitive total rewards package and is committed to pay equity and transparency. The posted pay range is based on possible base salaries for the role and does not reflect the full value of our total rewards package. Actual base pay determined at offer will be based on labor market data and a candidate's years of relevant work experience, education, certifications, skills, and geographic location.
Travel: Yes, 10 % of the Time
Flexible: Work location is on-site at a KP location, with the flexibility to work from home.
Worker location must align with Kaiser Permanente's Authorized States policy.
At Kaiser Permanente, equity, inclusion and diversity are inextricably linked to our mission, and we aim to make it a part of everything we do. We know that having a diverse and inclusive workforce makes Kaiser Permanente a better place to receive health care, a more supportive partner in our communities we serve, and a more fulfilling place to work. Working at Kaiser Permanente means that you agree to and abide by our commitment to equity and our expectation that we all work together to create an inclusive work environment focused on a sense of belonging and wellbeing.
Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status.
For jobs where work will be performed in unincorporated LA County, the employer provides the following statement in accordance with the Los Angeles County Fair Chance Ordinance. Criminal history may have a direct, adverse, and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment:
Consistently supports compliance and the Principles of Responsibility (Kaiser Permanente's Code of Conduct) by maintaining the privacy and confidentiality of information, protecting the assets of the organization, acting with ethics and integrity, reporting non-compliance, and adhering to applicable federal, state, and local laws and regulations, accreditation, and licensure requirements (where applicable), and Kaiser Permanente's policies and procedures.
Models and reinforces ethical behavior in self and others in accordance with the Principles of Responsibility, adheres to organizational policies and guidelines; supports compliance initiatives; maintains confidences; admits mistakes; conducts business with honesty, shows consistency in words and actions; follows through on commitments.
Job duties with at least occasional or possible access to: (1) patients, the general public, or other employees; (2) confidential protected health information and other confidential KP information (including employee, proprietary, financial or trade secret information); (3) KP property and assets, for example, electronic assets, medical instruments, or devices; (4) controlled substances regulated by federal law or potentially subject to diversion.
Submit Interest
Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status.
For jobs where work will be performed in unincorporated LA County, the employer provides the following statement in accordance with the Los Angeles County Fair Chance Ordinance. Criminal history may have a direct, adverse, and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment:
