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Shriners Children’s is an organization that respects, supports, and values each other. Named as the 2025 best mid-sized employer by Forbes, 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 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 FT or PT 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 and a Health Savings Account (HSA) if a High Deductible Health Plan (HDHP) is elected. Additional benefits available to FT and PT 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.

The Clinical Research Manager is a specialized, independent, management research professional who supports the Vice President, Research and the Corporate Director of Clinical Research with oversight and management of the system-wide clinical research operations, staff education, and compliance. This position’s responsibilities are to conduct clinical research audits to SHC location and to oversee the facilitation of appropriate and ethical clinical research activities in accordance with the protocol, SHC’s policies and procedures, SHC’s hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines.

Compliance

• Develops and oversees implementation of strategies necessary for minimizing risk of non-compliance.
• Conducts routine and regular reviews (auditing) of clinical research activities including (1) study specific essential documents, (2) investigator and study personnel qualifications, (3) data, and (4) data safeguards to ensure research is being conducted, recorded and reported in accordance with the protocol, policies and procedures, hospital regulations, Code of Federal Regulation, and Good Clinical Practice guidelines, where applicable.
• Monitors compliance risks to identify deviations and offer recommendations on controlling compliance issues, and develop and implement strategies necessary for minimizing risk of non-compliance.
• Responsible for carrying out regulatory compliance between investigators, research staff, SHC and external regulatory entities.
• Collaborates with investigators and other research staff to mitigate risk and to correct/address issues of non-compliance in a manner that limits recurrence and promote adherence to regulations.
• Evaluates protocols under initial consideration for regulatory requirements including SHC mission, feasibility, data collection, entry, storage and reporting.
• Confirms appropriate training and education, ensuring that site staff are qualified to safely perform study protocols.

Clinical Research Operations

• Directs and manages SHC system-wide processes and initiatives to standardize clinical research operations system-wide.
• Facilitates the research activities through collaborative, timely communications with SHC sites and external entities to contribute to the development and dissemination of policies and procedures related to research compliance/activities. Maintains and assists with the system wide use and daily operations of the clinical research management system used to oversee and monitor clinical research activities.
• Supervises the initiation and maintenance of all Human Subjects and Regulatory documents necessary for submission to SHC’s centralized Institutional Review Board. Proactively works with study sponsors, and various agencies in order to obtain initial and continued approval of all clinical trials/clinical research protocols.
• Has an extensive working knowledge of the complex clinical research process, from protocol development to implementation, including experience with clinical trials.
• Demonstrates knowledge of ethical standards set forth by the Belmont Report, the Nuremberg Code and the International Conference of Harmonization GCP standards.
• Exhibits a commitment to human subjects’ protection by providing the highest level of ethical and safety practices to protect all participants involved in research studies supported and approved by Shriners Hospitals for Children.
• Liaise with relevant authorities and professionals to analyze and develop standards for compliance

Education

• Interacts with sites providing education and support, with follow up as appropriate
• Provides guidance, under supervision of the Corporate Director of Clinical Research to investigators and research staff, in the interpretation of applicable regulations and guidelines, to include but not limited to GCP, GLP, ICH, FDA and DHHS guidelines.
• Implements and conducts on-going education and training for SHC research personnel related to clinical research activities, SHC policies and procedures, Good Clinical Practices, and regulations governing clinical research.
• Provides expertise, consultation and mentorship to SHC staff with respect to research processes and applicable regulations.
• Maintains education in human subject protection and good clinical practice principles, and applies knowledge of those ethical principles when interacting staff, subjects, and other entities.

This is not an all-inclusive list of this job’s responsibilities. The incumbent may be required to perform other related duties and participate in special projects as assigned.

Required:

• Bachelor's Degree in Clinical Laboratory Science or related field (5 or more years of experience in administration of clinical research will be accepted in lieu of Bachelor's degree in CLS or related field)
• Proficiency in MS Office
• Knowledge of applicable regulations related to product or agent being studied, the specific protocol, the informed consent process, and sponsors' policies and procedures
• Knowledge of regulation and guidance related to clinical research