Manager, Clinical Projects

U.S. Renal Care

About The Position

The Clinical Research Project Manager coordinates, executes, and reports on clinical study operations. This position provides leadership and support to members of the USRC Kidney Research division. Responsibilities encompass the overall management of a special project including, timeline adherence, internal and external education and training, internal and external communications, and project deliverables. The Project Manager acts as the liaison between the sponsor, academic collaborators, 3rd party vendors, USRC team members, and clinical sites while overseeing projects and ensuring quality service.

Requirements

Bachelor's degree in health care related field or equivalent combination of work experience and education will be considered in lieu of degree.
Three (3) to five (5) years of experience with clinical research working with patients and patient care providers.
Familiarity with FDA regulations, IRB requirements, and Good Clinical Practice.
Demonstrated proficiency in project management including planning, execution, delivery, and reporting.
Well-developed critical thinking skills and subsequent problem solving.
Valid drivers' license in applicable state. License must be maintained as current, without restrictions and good driving record.
Advanced computer skills, including Microsoft Office (Word, Excel, PowerPoint, Outlook and web-based tools) required; proficiency in USRC applications required within 90 days of hire.

Nice To Haves

Nephrology experience preferred.
Language proficiency in Spanish a plus.

Responsibilities

Assumes primary accountability for assigned research focused projects and initiatives and ensures compliance with applicable federal, state and academic regulations, and corporate policies for study activities.
Manages and executes the overall project scope and timelines. Develops and implements protocol and processes with internal USRC staff (e.g., facility managers, social workers, and nurses) and liaisons with external partners in achievement of these goals.
Ensures that all project tasks are completed in accordance with the contract, trial/project protocol, and Standard Operating Procedures (SOPs).
Provides administrative management and support for the receipt, shipment, and monitoring of study/project related samples and test results.
Manages resources associated with all study/project start-up and implementation activities.
Contributes to the development of study/project specific protocols, consent forms, and other trial-related materials (patient surveys, etc.) as required.
Assists with the development of educational content for assigned special projects.
Contributes to the development and implementation of project-specific data pipelines, processes, and workflows.
Assist with the implementation of project-specific procedures at the facility level Including onsite visits.
Contributes to the preparation and review of clinical data for analysis. Manages relationships with consultants to provide adequate support and services for data collection and analysis.
Serves as a liaison between clients, vendors, sites, collaborators, and internal team members (USRC and USRC Kidney Research) to ensure project specific information and ongoing updates are proactively communicated.
Plans for and manages all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, and equipment.
Monitors adherence to project contract and budget and reports to the VP of clinical research.
Responsible for tracking the completion of project-specific milestones and deliverables; responsible for reporting on project-specific metrics to USRC Kidney Research Leadership.
Collaborates with USRC Kidney Research Leadership to identify goals and scope of clinical study projects. Ensures operational and regulatory integrity of assigned studies and participates in FDA or other regulatory authority inspections, as needed.
Enhances department and organizational reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
Attends off-site meetings and conferences, as needed.
Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization.
Participates in team concepts and promote a team effort; performs duties in accordance with company policies and procedures.
Regular and reliable attendance is required for the job.