Clinical Research Coordinator I

Job Description

Job Description

Company Overview

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.

With 20+ hospitals, outpatient clinics, ambulatory care centers and outreach locations across the globe, we provide excellent care to children up to age 18 regardless of their family’s ability to pay or insurance status. Please click here to learn more about our locations.

Job Description

Study Management and Operations (Good Clinical Practice) 30%Study Management and Operations (Good Clinical Practice) Develops a contemporary knowledge of clinical research regulatory requirements. Has a working knowledge of clinical research process, from protocol development to implementation. Supports the investigators’ development of SHC investigator-initiated research protocols. Assists with the analysis of proposed research projects in order to determine appropriateness and feasibility at the local site, including the evaluation of resources required and regulatory requirements. Supports the implementation of approved research protocols. Ensures studies are conducted in compliance with the approved protocol, Good Clinical Practice (GCP) guidelines, applicable regulatory requirements, SHC policies and standards. Performs study-specific research activities and/or interventions, within the bounds of professional licensure. Responsible for tracking all aspects of projects including all study, investigator and Institutional Review Board (IRB) information and patient recruitment activity. Actively collaborates with applicable headquarters departments, including Research Programs, Legal, and Compliance related to protocol reviews, IRB submissions, sponsored contracts, material transfers, data use agreements, and HIPAA compliance for projects conducted within SHC. Works closely with investigators, research leadership, study sponsor and regulatory agencies to conduct, and report the results of clinical research. Responsible for oversight and documentation of the delivery, storage, and disposition of investigational products at the site, in accordance with federal and state regulations and sponsor requirements. Effectively provides information about the use of investigational products to patients. Understands and adheres to safety monitoring and reporting requirements of regulatory agencies that oversee use of an investigational product in research. CRC1 2 30%Data Management and Informatics Coordinates the collection of data throughout a clinical study including (1) timely data collection, (2) ensuring accurate data entry into secure research databases. (3) verifying data accuracy through internal quality control measures to confirm reported study data is accurate, complete, and verifiable from source documents. Participates data cleaning & database lock procedures in preparation for data analysis; provides timely responses to data queries, addresses data discrepancies, and reviews source documents. Contributes in compiling and preparing study results. Provides input into the dissemination of research results by verifying all regulatory and compliance criteria are met, confirming that the SHC system is credited appropriately. CRC1 3 30%Ethical and Participant Safety Considerations Demonstrates knowledge of ethical standards and issues with vulnerable pediatric populations. 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. Maintains education in human subject protection and good clinical practice principles, and applies knowledge of those ethical principles when interacting with subjects. Confirms appropriate training and education are in place to safely perform study protocols. Protects the rights and well-being of human subjects by (1) identifying & implementing safeguards for SHC’s vulnerable populations, (2) maintaining patient safety & privacy throughout the study, and (3) reporting any concerns or issues to appropriate departments, Collaborates with others to mitigate risk. Demonstrates an understanding of an ethical and legally effective informed consent process by (1) adhering to and applying protocol eligibility criteria when recruiting patients, and (2) effectively communicating with participants/families during the consent process. CRC1 4 10%Communication, Teamwork, and Professionalism Facilitates the local site’s research programs and projects through collaborative, timely communications and teamwork. Exhibits excellent communication and collaboration in all aspects of the research including (1) within the site; (2) between the site and the sponsor; and (3) 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. 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, dependability and the ability to work effectively with a wide range of individuals. Develops a contemporary knowledge of clinical research regulatory requirements.

The pay range for this position is $26.58 - $39.86. Compensation is determined based on years of relevant experience and departmental equity.