Clinical Research Program Manager

Company Overview

#LI-Remote

Shriners Children’s is an organization that respects, supports, and values each other. We are engaged in providing excellence in patient care, embracing multi-disciplinary education, and research with global impact. We foster a learning environment that values evidenced based practice, experience, innovation, and critical thinking. Our compassion, integrity, accountability, and resilience define us as leaders in pediatric specialty care for our children and their families.

 

All employees are eligible for medical, dental and vision coverage on their first day! In addition, upon hire all employees are eligible for a 403(b) and Roth 403 (b) Retirement Saving Plan with matching contributions of up to 6% after one year of service. Employees in a full-time or part-time status (40+ hours per pay period) will also be eligible for paid time off, life insurance, short term and long-term disability and the Flexible Spending Account (FSA) plans. Additional benefits available to full-time and part-time employees include tuition reimbursement, home & auto, hospitalization, critical illness, pet insurance and much more! Coverage is available to employees and their qualified dependents in accordance with the plans. Benefits may vary based on state law.

Job Overview

The Clinical Research Program Manager (CRPM) is a specialized, independent research professional who is responsible for operational management, overseeing all local SHC clinical research activities. Reporting to the Research Programs Office at SHC International Headquarters, the CRPM provides support and leadership in accordance with SHC’s policies and procedures, SHC’s hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines, when applicable. The Retrospective Core CRPM works closely with investigators f and other research personnel to ethically review data from SHC’s vulnerable pediatric subjects and to appropriately collect and safeguard data. Overall, the Retrospective Core CRPM is the system’s primary liaison among research participants, study staff, the investigator(s) and study sponsor(s), related to retrospective studies. This position’s main responsibilities are to help ensure proper study conduct and the quality of data and data safeguards for retrospective studies.

 

This position will provide management of the retrospective studies within the clinical research program, ensure competent and standardized staff practices, and coordinate strategies to enhance interdisciplinary communication and collaboration. the Retrospective Core CRPM is responsible for direct oversight and reporting for the CRCs working in the retrospective core.

Responsibilities

Project Management and Operations

• Accountable for the retrospective core’s  research activities. Facilitates the Retrospective Core’s  research projects through collaborative, timely communications and teamwork. Exhibits excellent communication and collaboration in all aspects of the retrospective research program; between the site and the sponsor; and with appropriate outside entities. Establishes and maintains collaborative relationships with all involved in clinical research operations. Fosters teamwork by respecting and valuing the contributions of all involved in the clinical research process. 
• Works effectively with SHC leadership to ensure the research mission is upheld. Maintains a contemporary knowledge of clinical research regulatory requirements. Has an extensive working knowledge of the complex clinical research process, from protocol development to implementation, including experience with clinical trials. Contributes to the strategic plan for the research program including short-term and long-term objectives.
• Coordinates with other members of the  Department of Research Programs regarding clinical research activities, including OnCore, audits, and regulatory compliance issues.  Proactively collaborates with others in the Department of Research Programs to train and support research staff including the development of work aides, templates and guidelines, policies, and initiatives aimed at improving process and efficiency
• Provides expertise, consultation and mentorship to Retrospective Core’s  staff. Serves as the primary point of contact, liaison and resource for the Retrospective Core’s  staff related to research, professional development, SHC research management processes, Good Clinical Practices, regulations, and policies governing clinical research. 
• Takes a leadership role in implementation of process development and improvement changes, as needed.
• Directs education and training of retrospective core clinical research staff. Assures that all key personnel or persons “engaged” in a research project have met training requirements in accordance with Federal, Institution and sponsori