Clinical Research Coordinator II

Overview

The Clinical Research Coordinator II is a specialized, independent research professional who ensures oversight and compliance of both system-wide and local SC (Shriners Children's) clinical research activities. Reporting to the Clinical Research Program Manager (or local Hospital Administrator/Clinic Director) and Research Programs Office at SC International Headquarters, the CRC II provides support in accordance with SC’s policies and procedures, SC’s hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines, when applicable. The CRC works closely with the Chief of Staff, SHC scientific and medical staff and other research personnel to ethically recruit and consent SC’s vulnerable pediatric subjects and to appropriately collect and safeguard data. Overall, the CRC II is the site’s primary liaison among research participants, the local investigator(s) and study sponsor(s). This position’s main responsibilities are to help ensure proper study conduct, subject safety, and the quality of data and data safeguards.

Responsibilities

Study Management and Operations (Good Clinical Practice)

• Maintains a contemporary knowledge of clinical research regulatory requirements. Has a working knowledge of the complex clinical research process, from protocol development to implementation.
• Supports the investigators’ development of SC investigator-initiated research protocols. Performs critical analysis of proposed research projects in order to determine appropriateness and feasibility at the local site, including the evaluation of resources required, budgeting, 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, SC policies and standards.
• Responsible for tracking all aspects of projects including all study, investigator and Institutional Review Board (IRB) information, patient recruitment activity, and financial management. 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. Provides direction and education to clinical research staff on protocol-related activities.
• 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 monitoringand reporting requirements of regulatory agencies that oversee use of an investigational product in research.

Data Management and Informatics

• Coordinates the collection, statistical analysis and dissemination of data results 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 to share with research team. Provides input into the dissemination of research results by verifying all regulatory and compliance criteria are met, confirming that the SC system is credited appropriately, and assisting with abstract and manuscript preparation and submission as applicable.

Ethical and Participant Safety Considerations

• 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 Children's.
• Maintains education in human subject protection and good clinical practice principles, and applies knowledge of those ethical principles when interacting with subjects. 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 SC’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 Children's. Maintains patient safety and 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.
• Adheres to and applies protocol eligibility criteria when recruiting patients. Demonstrates a clear understanding of an ethical and legally effective informed consent process. Effectively communicates with participants/families during the consent

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 program within the site; 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 SC 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.

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.

Qualifications

Required:

• 3 or more years Clinical Research experience, e.g. experience with site management, study management, IRBs, and federal regulations regarding clinical research compliance
• Bachelor's Degree, or 5+ years of specific job-related experience in the administration of clinical research in lieu of degree

Preferred:

• Bachelors degree in clinical research, science or other healthcare related field
• Master’s degree in clinical research, science or other healthcare related field
• CCRP or CCRC certification