Research Data Coordinator - Pediatrics Patient Care

Research Data Coordinator

The ideal candidate will have a Bachelor’s degree and be interested in a career in clinical research.

JOB-SPECIFIC COMPETENCIES
Data Management

• Assists the principal investigator in the collection and evaluation of clinical research data.
• Abstracts and collects patient data from electronic health records and other relevant source documents.
• Demonstrates ability to gather information and determine the appropriate information to report.
• Enters research study data into paper or electronic case report forms (CRFs) or local data systems as required, in accordance with protocol requirements and departmental timelines.
• Performs ongoing and concurrent review of data to ensure completeness and accuracy.
• 解决数据输入遗漏或不一致之处，并及时修改错误。
• 提供研究进度和患者安全报告的数据，例如IRB持续审查和IND报告。
• Follows and adheres to department and sponsor guidelines to accomplish and complete daily work.

Protocol Management

• Under the supervision of the principal investigator (PI) and research data supervisor/manager, assists the investigator in the overall conduction of assigned clinical trials.
• Participates in Site Initiation Visits (SIVs), conference calls, and protocol meetings.
• Tracks and manages all relevant protocol paperwork and essential documents in accordance with sponsor requirements and institutional policies and procedures.
• Tracks protocol-required patient labs, tests, visits, and procedures through the electronic health record.
• Maintains knowledge of and assists in recording adverse events.
• 为部门合同和预算团队成员创建，维护并提供状态报告，以帮助促进适当的学习付款。
• Provides coverage for other data coordinators, informs appropriate staff, and arranges coverage for necessary functions when absent.

Clinical Trials Coordination

• 关于正在进行的研究，咨询主要研究员和其他部门的人员或书面书面咨询。
• 通过电话，计算机生成的报告和/或面对面的，与其他机构和机构（即NCI，制药公司，赞助机构等）联系时，可以展示出色的口头和书面沟通技巧。
• Prepares reports for the sponsoring agency, as specified by reporting requirements (e.g., monthly, quarterly, semiannually, and annually).
• Coordinates and participates in monitoring visits and internal or external audits to ensure objectives are met.
• Coordinates with research staff to identify and address any study-related issues, including but not limited to inadequate or missing source documentation, adverse event reporting, and protocol deviations or violations.
• Applies knowledge and experience when addressing study issues, gathering relevant information systematically, and making sound decisions.
• Acts as a liaison with the research team, caregivers, patients as well as other institutions and agencies and initiates, develops, and manages these relationships and networks.
• Works in situations involving uncertainty, shifting priorities, and rapid change dealing constructively with mistakes and setbacks, and demonstrating flexibility.
• Maintains a level of professional expertise and credibility through attendance at both institutional and outside continuing education programs.

Other duties as assigned