Clinical Research Project Manager

Description

About CBCC:
Comprehensive Blood & Cancer Center (CBCC) believes in putting our patients first. Our team stays up to date on the latest and greatest in modern holistic care, ensuring our treatment strategies are optimized for peak mental and physical wellness.
Our objective at CBCC is to facilitate high-quality patient care through our mission statement;
"CHANGING LIVES WITH HOPE AND INNOVATION" and 5 Pillars of Excellence: Quality, Services, People, Community, and Innovation.
CBCC is a privately owned center that is conveniently located approximately 2 hours north of Los Angeles, 4.5 hours from Las Vegas, and about a 2-hour drive to the amazing California coastline and beautiful beaches. Our location in Bakersfield provides the convenience of experiencing California living without the high cost of living. We care for our employees and believe work-life balance is a must.

Education & Experience:

• Bachelors in Life sciences or equivalent
• Strong knowledge of Clinical Research process, including working knowledge of all functional areas of clinical trials and medical terminology
• At least 5-6 years of monitoring / Clinical Research Associate experience in Clinical Research
• Oncology & Ophthalmology experience preferred.

Essential Duties and Responsibilities

• Overall Project Management of the assigned projects starting from project initiation till closure of the project.
• Ensure the project delivery as per defined quality standards, Protocol, service agreement, SOPs, GCP and other applicable guidelines.
• Set up feasibility team and to delegate the activities to feasibility team.
• Coordinate with regulatory consultant/designee for regulatory submission and approval process.
• Coordinate with Sponsors throughout the project cycle for delivery of project as per contract.
• Set up project team in conjunction with Project Director and to delegate the activities to study team
• In consultation with Project Director, identify the scope of the project that needs to be outsourced to third party and shortlist the potential Vendors for the same from CBCC database, or else coordinate with Project Director, and QA to identify and qualify new vendors as per project specific requirement.
• Site finalization in consultation with Project Director, & Budget negotiation and finalization of CTA with Site
• Coordinate with Vendors (EDC, Central Lab etc) for the setting up the system as per the project specific requirement in a timely manner.
• Develops project plan, including all elements listed in the CBCC project plan template as appropriate for the project (Project milestone and Timelines, Roles and Responsibilities, WBS, Communication Plan, Risk Analysis, monitoring plan, Quality Management etc).
• Ensures that study specific management tools, trackers and Trial Master File Maintenance plan are set up before project initiation and maintain throughout the project life cycle.
• Implement the internal quality management program for internal audit for each clinical study assigned.
• Participate and support project related external audits
• Coordinate with Sponsor/Vendors (EDC, Central Lab etc) for Project specific Training of CBCC team
• Coordinate PI meeting wherever necessary
• CBCC Project team training on the project and training evaluation
• Preparation of project specific training material for SIV and perform Site initiation visits with CRA, for onsite training to site staff. Ensuring adequate study team training including training evaluation.
• Perform the periodic review for the project with study team and update the status of the project to sponsor and management periodically.
• Overall budget management (including review and approval of Site Invoice and Vendor Invoice) for the trial
• Co-Monitoring for training of CRAs (pre-study, initiation & training, routine, and close-out visits)
• SAEs, SADEs or UADEs management as per the protocol and its reporting to the concerned parties and regulatory, as applicable.
• Maintaining the quality within the study through regular review and if required prepare and implement CAPA
  in case of any quality issues identified, in consultation with Head PM and QA team.
• Identification of quality issues within the study through regular review of the clinical study team communication & documentation.
• Tracks metrics of Clinical Research Projects assigned and provide project metrics, project status reports and other administrative reports to Sponsor and senior management throughout the project.
• Supervises activities of the project CRAs, including the scheduling of monitoring visits, other activities associated with the project (e.g., review of visit reports for completeness and accuracy, assisting monitors with problem sites, etc.), and time accountability for the project.
• Assists and guides CRAs in conducting Pre-Study Visit, Site Initiation & Training Visit, Interim Site Monitoring and Closeout Visits as needed. May also have monitoring responsibilities within the projects as per the requirement.
• Tracks project timelines, milestones and budget requirements for assigned projects
• Reconcile work done against invoices and track out of scope tasks.
• Drafting and development of standard procedures of new department, services, and annual revision of CBCC Standard Procedures.
• Supervise, train, and mentor Clinical Staff and new recruits within CBCC.
• Participate in Clinical research training program as a trainer.
• Support proposal making of clinical trial inquiries, if required.
• Ensures compliance with the Quality Standard requirements of quality management system and relevant documentation and filing.
• To work as per GCP, New Drugs and Clinical Trials Rules 2019, Medical Device Rules 2017, other applicable regulations and to Ensure Compliance for the same.
• Any other task assigned by HOD/Designee

Requirements

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.