The Lead-Data Clinical Research Coordinator’s primary responsibility is to develop, oversee and implement the conduct of data related to clinical trials in the division of Hem/Onc/BMT Clinical Research Office. This position will focus on the conduct of data related to Investigator Initiated Trials (IIT) and industry sponsored related trials under the direction of Hem/Onc/BMT Clinical Research Office.
The Lead-Data Clinical Research Coordinator will collaborate with the Lead-Clinical Research Coordinator and Quality & Regulatory Coordinators to develop process of collecting, extracting and analyzing data, plans, organizes, and implements the execution of IIT, Industry and NCI research data.
This position is also responsible for but not limited to; standard operating procedures related to data management functions, assignment of team workflow to meet data deadlines, oversight of quality initiative, monitoring visits, productivity to ensure fulfillment of research goals, training and scheduling of research personnel, develops new case report forms for new studies, ensures all requirements of studies are met, plan and leads meetings for protocol data planning, Quality assurance, monitors protocol compliance, creation of Data safety monitoring reports, development of DSMB for IIT protocols, oversees auditing and site visit preparation for all studies.
1. Responsible for development and implementation of conduct of data collection as it relates to clinical trials in Hem/Onc/BMT.
2. Responsible for the organization of, and participation in disease team meetings and teleconferences, including scientific meetings with corporate and non-profit partners, teaching conferences, grand rounds, journal club, research seminars, and CME programs. Maintains logs of all training and certificates.
3. Supports the conduct of clinical human subject research as outlined in the study protocol; performing study procedures according to recognized skill level and certifications and within the local and federal regulations and guidelines adheres to Good Clinical Practices. Focus on conduct of data collection as it relates to IIT, and Industry sponsored research trials.
4. Coordinates the day to day operations of the clinical research coordinators data collection in the division of Hem/Onc/BMT. Supports the research nursing staff, Lead-Clinical Research Coordinator and clinical research coordinators and educates them in prepare and processes human subject data collection for use in research studies.
5. Works in collaborations with department/center investigators in the development of IRB protocols, grant submissions and scientific publications, quality and regulatory teams, EPIC Beacon team, Monitors and auditors to ensure the quality and compliance of data collection timeliness and in regards to each protocols requirements.
6. Coordinates and trains data personnel for the program and projects; oversees and organizes training for study protocols within the Division of Hematology/Oncology/BMT. Coordinates education to all of the necessary staff to obtain the objects of the research study.
7. Collects and controls research data and subject information and maintains accurate data collection of all study data; including tests and procedures related to study compliance.
8. May be responsible for administrative management of multiple protocols; plays a central role in the communication between NCH/RI and site; will act as liaison with other departments necessary to complete program projects (i.e., Data Management, Biostats, Medical Writing, Regulatory Compliance, etc.)
9. Manage the reporting to adverse events and report to IRB in a timely manner., ensuring sites are submitting accurate and timely IRB submissions, and maintain associated regulatory documents. Ensure training and compliance of all participating sub sites.
10. Help facilitate creation of source documents, data safety monitor reports, and summaries that ensure systematic data collection and/or aid in protocol execution and management and record keeping
11. Collects and controls research data and subject information from sites as needed/requested; tracks screening and enrollment data across multiple sites/multiple projects
12. Provides monitoring, review and tracking of clinical data and preparation of study specific documents according to FDA regulations.
13. QA process implementation, maintenance and documentation; data entry; and maintenance of regulatory documents for multiple sites; multiple protocols. QA process will provide feedback to the clinical research coordinator nursing staff on quality improvement areas. Monitoring results and audit results may also be reviewed and QA processes implemented based on findings.
14. Responsible for supporting sub sites education, questions, start up, continue screening and identifying patients, and data collection questions. Educate subsites on the CRF as they relate to the study specific documents. Work with principal investigators at each site to establish multi-site monitoring plans for investigator initiated projects (If applicable).
15. Performs other duties and maintains flexible schedule as required