协调员 II，临床研究
Coordinator II, Clinical Research
公司简介
Shriners Children’s 是一个尊重、支持并重视彼此的组织。被福布斯评为2025年最佳中型企业雇主，我们致力于提供卓越的患者护理，拥抱具有全球影响力的多学科教育和研究。我们营造一个以循证实践、经验、创新和批判性思维为价值的学习环境。我们的同理心、诚信、责任感和韧性定义了我们在儿科专科护理领域的领导地位，为我们的儿童及其家庭服务。
我们在全球拥有20多家医院、门诊诊所、日间护理中心和外展地点，无论家庭的支付能力或保险状况如何，我们都为18岁以下的儿童提供优质的护理。请点击此处了解我们的更多地点信息。
现任员工：请登录 Workday 点击此处通过“职位中心”内部申请
职位描述
临床研究协调员，二级（CRC2）是一项专业且独立的研究职位，负责对 Retrospective Core 的系统范围内的 SHC 临床研究活动进行监督和合规管理。向 SHC 国际总部研究项目办公室的 Retrospective Core 临床研究项目经理（CRPM）汇报，CRC 根据 SHC 的政策和程序、SHC 的医院规定、联邦法规代码以及适用的良好的临床实践指南提供支持。CRC 与 CRPM、SHC 科学和医学研究人员及其他研究工作人员密切合作，以适当收集和保护数据。该职位的主要职责是确保研究的正确实施、管理和数据及数据保护的质量。
主要职责：
- 保持对临床研究监管要求的最新了解。具备从方案开发到实施的复杂临床研究流程的实践经验。
- 通过 Retrospective Core 支持研究人员制定 SHC 自主发起的研究方案。
- 支持已批准的研究方案的实施。
- 确保研究按照批准的方案、良好临床实践（GCP）指南、适用的监管要求、SHC 的政策和标准进行。
- 负责跟踪所有项目方面的内容，包括所有研究、研究人员和机构审查委员会（IRB）相关事项
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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.
CURRENT EMPLOYEES: Please log into Workday Click Here to apply internally through the "Jobs Hub"
Job Description
The Clinical Research Coordinator, Level 2 (CRC2) is a specialized, independent research professional who ensures oversight and compliance of system-wide SHC clinical research activities for the Retrospective Core. Reporting to the Clinical Research Program Manager (CRPM) of the Retrospective Core in the Research Programs Office at SHC International Headquarters, the CRC provides support in accordance with SHC’s policies and procedures, SHC’s hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines, when applicable. The CRC works closely with the CRPM, SHC scientific and medical staff investigators and other research personnel to appropriately collect and safeguard data. This position’s main responsibilities are to help ensure proper study conduct, management, and the quality of data and data safeguards.
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
Compensation is determined based on years of relevant experience and departmental equity.Originally posted on Himalayas