Clinical Research Manager

We are looking for the brightest and the best to join our team!

Are you under challenged in your current position? Do you want to contribute to making a difference in the lives of patients and families on their medical journey? Do you find joy and fulfillment from helping others? Join our team as a Clinical Research Manager, where you can make a difference every day.

Two major benefits offered by Cure 4 The Kids Foundation

• One of the most competitive compensation and comprehensive benefit packages in the field of healthcare
• A state-of-the-art clinical and administrative environment located at 215 and Town Center, Summerlin on the Roseman University Campus

Cure 4 The Kids Foundation was voted #10 on the list of the Best Non-Profits to Work for in the U.S.

WHAT IT TAKES TO BE PART OF OUR TEAM
Are you an exceptional Research Manager who absolutely thrives on being part of an accountable team? Can you dedicate yourself to being part of a team serving the needs of children and their families? Do you bring the highest standards of integrity and professionalism to your team? Do you thrive in an environment where you are valued and appreciated for who you are, how hard you work and for that something special you bring to the teams you choose to work with? Are you looking for an organization that offers competitive compensation and one of the broadest and most comprehensive benefit packages available in the field of healthcare?

If you said yes to all of these questions and feel you can add to our culture, please keep reading...

This is a role that requires a multi-disciplinary team approach to solving problems and patient challenges. "That's not my job" or "someone else can do it" is not in our team vocabulary because we are here to be of support to each other. The primary goal is to bring the best patient care and experience for our area's children.

POSITION DESCRIPTION: The Clinical Research Manager provides leadership and direction to the Clinical Research Associates, ensuring high-quality, compliant clinical trial monitoring. This role serves as a liaison with investors and is responsible for research, preparing, submitting, and managing grant proposals and reports in alignment with organizational goals and funder requirements. This is a salaried, exempt position.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Leads site management and clinical monitoring in accordance with contractual agreements, department guidelines, SOP's, applicable international, federal and state regulations and IRB guidelines.
• Serves as the main point of contact for sponsors and investigators.
• Identifies challenges with study timelines/deliverables and offers creative action plans and develops standard operating procedures.
• Coordinates with the Principal Investigator and department to help ensure that clinical research and related activities are performed in accordance with federal regulations, as well as organization, and sponsoring agency policies and procedures.
• Completes study documentation and maintains study files in accordance with sponsor requirements and organizational policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, and case report forms.
• Communicates deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator.
• Conducts monitoring tasks in accordance with approved monitoring plan.
• Escalates observed deficiencies and issues to clinical management and follows all issues through to resolution.
• Tracks trends of queries and protocol deviations and implements process improvement initiatives.
• Verifies all reported trial data is accurate, complete, and verifiable from source documents in coordination with the Clinical Research Associates.
• Manages internal research trials and registries (e.g., iRest, Unlikely Collaborators Grant, SCD, and other indication-specific dashboards).
• Oversees that trials are in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements.
• Inventory of product and medication.
• Researches, applies for, administers, supervises, coordinates, and monitors deferral, state, and local grants in compliance with applicable standards, regulations, and guidelines.
• Prepares monthly reports on funded and non-funded project status.
• Maintains and verifies payment records.
• Performs other duties as assigned.

SUPERVISORY RESPONSIBILITIES:

• Directly supervises the Clinical Research Associates within the research department.
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• While the Principal Investigator is primarily responsible for the overall conduct and management of the clinical trial, the supervisor supports, facilitates, and coordinates daily clinical activities and plays a critical role in the conduct of studies.
• Responsible for the leadership of other Clinical Research Associates, driving the team to ensure efficient and quality conduct of studies.
• Responsibilities include interviewing and training employees; planning, assigning, and directing work; appraising performance; and resolving problems.

REQUIRED EDUCATION AND EXPERIENCE:

• Bachelor's degree in science or health-related field or a high school diploma with equivalent experience.
• A minimum of three (3) years of experience directly related to the duties and responsibilities specified.
• Completion of certification in clinical research project/program management.
• Valid driver's license and automobile liability insurance.

PREFERRED EDUCATION AND EXPERIENCE:

• Completion of an allied health degree (e.g., Respiratory Therapy, Radiology Technology, and Licensed Practical Nurse) or an associate degree in clinical Trials Research Related Curriculum.
• Previous experience in leadership and supervision.
• Experience in obtaining grants or administration of grants.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Excellent organizational skills, attention to detail, and a customer service demeanor.
• Strong interpersonal, collaborative, and time management abilities.
• High proficiency with full Microsoft applications.
• Strong analytical, meeting management and leadership skills.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

• Frequently required to sit for 7-8 hours daily at a computer terminal.
• Occasionally required to stand, walk, and lift/push/carry items up to 15 pounds.

Shift Schedule: Monday-Friday