Research Coord

Company Overview

The Shriners Children's team aspires to be the model of excellence and leadership in human resources, offering strategic and innovative solutions and tools to support our mission, vision and strategic plan. We seek to model our core values in our daily work as we strive to become an employer of choice. Shriners Hospitals for Children Mexico is where hope and support meet.

Coordinates the timely collection of data throughout the clinical study. Evaluates feasible protocols under consideration, including the data collection, entry, storage, and reporting process. Assists in the development of processes to standardize data management and collection, including data protection by protocol. Verifies the accuracy of data through internal quality control measures to confirm that the reported study data is accurate, complete, and verifiable from original documents. Ensures accurate data entry into protected research databases. Verifies data through quality control measures to confirm the credibility of the study data, that it is complete, and verifiable according to the source. Participates in a timely manner in data cleaning and database lock procedures in preparation for data analysis. Provides timely responses to data inquiries, addresses data discrepancies, and reviews source documents. Contributes to the collection and preparation of results to share with the research team. Provides information for the dissemination of results, ensuring that all regulatory and compliance criteria are met. Responsible for overseeing site research activities and clinical research staff. Directs and manages the education and training of clinical research staff and hospital personnel. Supervises that all staff or key individuals "participating" in a research project meet training requirements according to federal, institutional, and sponsoring agency regulations. Organizes and manages resources and services to successfully implement and monitor the progress of clinical research, supervises the timely collection of data, addresses data discrepancies, and coordinates the preparation of summaries and manuscripts as appropriate. Collaborates with the Research Programs Department and hospital administration in overseeing clinical research activities, including OnCore, budgets, audits, and regulatory compliance issues. Routinely collaborates with the Research Programs Department to develop, manage, and execute projects and initiatives across the HSN system. Leads the Genomics Institute project in Mexico City and ensures the continuous collection of samples for shipment to the HSN Genomics Institute Laboratory in Tampa FL. Applies knowledge of the ethical standards established by the Belmont Report, the Nuremberg Code, and the good clinical practice standards of the International Conference on Harmonisation. Demonstrates expertise in the protection of human subjects 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. Maintains education on the protection of human subjects and the principles of good clinical practices, and applies knowledge of those ethical principles when interacting with subjects. Evaluates ethical issues related to vulnerable pediatric populations and implements additional safeguards that must be applied to vulnerable HSN populations. Reports any concerns or issues directly to the Research Programs Department or other appropriate departments for follow-up. Protects all participants included in a clinical research study supported and approved by Shriners Hospitals for Children. Maintains patient safety and privacy throughout the study. Protects the rights and welfare of human subjects. Ensures the implementation of appropriate training and education to safely conduct study protocols. Collaborates with researchers and the rest of the research staff to mitigate risk and implement control processes. Complies with and applies protocol eligibility criteria when recruiting patients. Communicates effectively with participants or families during the consent process to cover all essential elements, including study concepts and the risk/benefit relationship. Facilitates site research programs and projects through collaborative and timely communications, as well as teamwork. Demonstrates excellent communication and collaboration in all aspects of research, including within the site, between the site and the sponsor, and with appropriate external 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. Reports any concerns or situations directly to the research projects department or other involved departments. Responsible for supervising and documenting the delivery, storage, and disposal of research products on site; in accordance with federal, state regulations, and sponsor requirements. Provides information effectively about the use of research products to patients. Understands and adheres to the reporting and safety monitoring requirements of regulatory agencies overseeing the use of a research product. Demonstrates professionalism and leadership skills by applying the professional guidelines and code of ethics established by HSN and the relevant regulatory agencies related to conducting clinical research. Works effectively with HSN leadership to ensure that the research mission is upheld. Maintains scientific integrity, intellectual honesty, and excellence. Interacts with other departments in a professional and timely manner to facilitate research coordination. Demonstrates interpersonal and professional skills, including but not limited to, professional appearance, tact, planning, punctuality, reliability, and the ability to work effectively with a wide range of people. Maintains contemporary knowledge of regulatory requirements for clinical research.