Provide experienced study
coordinator/data management/regulatory specialist support to the Clinical
Trials Office (CTO). Manage independent assignment as well as providing
training and mentoring to team members as required. Manage supervisor
responsibilities as required. This position is integral to the overall
efficient operation of the
CTO
.
Facilitate excellent customer service and guidance in the clinical trials arena.
Responsibilities:
Assure all studyrequirements are documented and meet both internal and externalregulations in accordance with protocol guidelines.
Maintain logs,including tracker submissions and update the CTO Oncore database in atimely manner according to CTO SOPs.
Manage all patientand /or protocol data as assigned, respond to queries in a timely fashion.
Schedule andparticipate in monitoring visits and participate in multidisciplinary teamprogram meetings as required.
Assistmultidisciplinary team in research activities. Serve as a consultant tofaculty and support staff.
Bachelor's degree
and two or more years experience coordinating clinical trials: or equivalent
combination of education/experience that includes at least four years in the
clinical trials arena.
science experience/education strongly preferred.
certification required prior to assuming Clinical Research Coordinator IlI role.
understanding of Good Clinical Practice guidelines, Code of Federal
Regulations, clinical trials monitoring, regulatory compliance.
the Microsoft suite including Excel and Power point.
- Exceptional interpersonal skills required and excellent
verbal and written communication skills necessary to effectively deal with
individuals both inside and outside the organization from diversified backgrounds.
communicating sensitive/difficult information and maintaining highly
confidential information and situations.
high level of interpersonal skills and analytical ability.
writing and organizational skills
leadership abilities required including mentoring and training.
initiative and attention to detail including coordination of complex studies
and increased workload.
- Successful completion of Level III promotion presentation to applicable
CTO Management demonstrating the above qualifications and competencies.
Equal Opportunity Employer of Minorities/Females/Disabled/Veterans