Coordinator II, Clinical Research

Key Responsibilities:

• Maintains a contemporary knowledge of clinical research regulatory requirements. Has a working knowledge of the complex clinical research process, from protocol development through implementation.

• Supports the investigators’ development of SHC investigator-initiated research protocols via the Retrospective Core.

• 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.

• Responsible for tracking all aspects of projects including all study, investigator and Institutional Review Board (IRB) information. 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, Retrospective Core team members, study sponsor and regulatory agencies to conduct and report the results of clinical research.

• Coordinates the collection and management of data throughout a clinical study. Evaluates protocols under consideration for feasibility, including the process for data collection, entry, storage and reporting. Assists in the development of procedures to standardize data collection and management, including the safeguarding of data, for each protocol. Responsible for timely data collection. Ensures accurate entry of research and outcome data into secure research databases. Verifies data accuracy through internal quality control measures to confirm reported study data is accurate, complete, and verifiable from source documents. Provides timely responses to data queries; reviews source documents and addresses data discrepancies. Participates in timely and thorough data cleaning and database lock procedures in preparation for data analysis.

• Contributes in compiling, critically analyzing and preparing study results, when applicable. Provides input into the dissemination of research results by verifying all regulatory and compliance criteria are met and assisting with abstract and manuscript preparation and submission, as applicable.

• 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. Maintains education in human subject protection and good clinical practice principles, and applies knowledge of those ethical principles. Possesses a thorough understanding of the ethical issues involved with vulnerable pediatric populations, and identifies and implements additional safeguards that should be in place for SHC’s vulnerable populations. Reports any concerns or issues directly to the Department of Research Programs or other appropriate departments for follow-up.

• Safeguards all participants involved in a research study supported and approved by Shriners Hospitals for Children. Maintains patient privacy throughout the study. Collaborates with investigators and other research staff to mitigate risk. Protects the rights and well-being of human subjects. Confirms appropriate training and education are in place to safely perform study protocols.

• Facilitates Retrospective Core projects through collaborative, timely communications and teamwork. Exhibits excellent communication and collaboration with the project investigator, Retrospective Core team and sponsors; 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 scientific integrity, intellectual honesty, and excellence.

• 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 in a diverse community.

• Provides expertise consultation and mentorship to site staff, residence, students, and volunteers with respect to research processes, Good Clinical Practices, and regulations governing clinical research. Interacts with other departments in a professional and timely manner to facilitate research coordination.

Required Qualifications:

• 3 years of clinical research experience, e.g. experience with site management, study management, IRBs, and federal regulations regarding clinical research compliance

• Bachelor's Degree in clinical research, science or other healthcare related field - or 5 years of specific job-related experience in the administration of clinical research

Preferred Qualifications:

• Experience in the coordination of intergroup or multi-site clinical studies

• Experience with data management including creating data dictionaries, monitoring data for completeness, preparing data sets for analysis.

• Experience and interest in working with the pediatric population and/or pediatric orthopedics

• Experience with coding languages such as Python and SQL

• CCRP or CCRC certification