CLINICAL RESEARCH COORDINATOR
2 weeks ago
* Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned.
* Understands and can conduct clinical research studies that require but not limited to, DSMB, Emergent Access, Conduct Investigator Initiated studies, Multi-site clinical trials, Research Team training manuals.
* Achieves clinical research coordinator certification from ACRP or SOCRA after two years in the position.
* Supporting NCCBD's NCORP: NCI Community Oncology Research Program across the Nemours enterprise.
* Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements.
* Performs clinical data gathering and measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases.
* Mentors new clinical research coordinators. Participates in training nursing and ancillary study staff for study purposes; recruits, screens and enrolls sufficient number of study participants in conformance with protocol requirements.
* Assists in identifying, reporting and following-up on Serious Adverse Events.
* Assists in the maintenance of study medication accountability records; prepares clinical specimens for shipment to central laboratories.
* Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.
* Attendance at and participation in relevant clinical divisional/departmental activities to assure routine administrative procedures are followed. Further attendance at Sponsor Coordinator meetings as needed for study related training.
QUALIFICATIONS:
* Bachelor's degree in medical or science related field required;
* Clinical Research Coordinator certification or eligible to sit for exam after 2 years clinical research coordination experience
* Effectively uses Microsoft computer software;
* Maintains the highest possible standards for work quality; accepts feedback; gives accurate information
* Builds and fosters professional relationships with staff, families, and patients
* Makes decisions when appropriate; manages resources prudently; schedules time efficiently; works independently
* Demonstrates ability to coordinate and establish priorities among diverse tasks;
* Effectively communicates verbally and in writing with patients, families, associates, and providers;
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