Description
The Clinical Research Coordinator contributes to the overall operational management of clinical research/trial/studyactivities from design, set up, conduct, through closeout. The position has responsibility for the implementation of researchactivities for one or more studies. The incumbent recognizes and performs necessary tasks to manage projects and prioritizes work to meet necessary deadlines. The incumbent is responsible for planning and organizing necessary tasks toensure adherence to the study protocol and applicable regulations, such as institutional policy and procedures, FDA Codeof Federal Regulations (CFR), and ICH Good Clinical Practice (GCP). The Study Coordinator collaborates with thePrincipal Investigator (PI), ancillary departments, central research infrastructure teams, sponsors, institutions, and otherentities as needed to support the administration of all aspects of studies, including, but not limited to, compliant conduct,financial management, and adequate personnel support. The responsibilities outlined in the job description provide ageneral overview of duties and tasks performed by Clinical Research Coordinators. Performance of duties and tasks willvary based on the department operations, the type of study and scope of service. Hourly range: $35.31-$56.82
Qualifications
Required:
- Bachelors Degree or 2+ years of previous study coordination or clinical researchcoordination experience
- Interpersonal skills to effectively communicate information in a timely, professionalmanner and establish and maintain cooperative and effective working relationships withstudents, staff, faculty, external collaborators and administration and to work as amember of a team.
- Ability to set priorities and complete ongoing tasks with competing deadlines, withfrequent interruptions, to meet the programmatic and department needs, while complyingwith applicable University policies and federal and state regulations.
- Analytical skills to assess clinical research protocols and regulatory requirements, defineproblems, formulate logical solutions, develop alternative solutions, makerecommendations, and initiate corrective actions.
- Close attention to detail to ensure accuracy in a fast-paced, fluctuating workloadenvironment.
- Organization skills to create and maintain administrative and regulatory files effectivelyas well as independently balance the various tasks to ensure deadlines are met.
- Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, toperform daily tasks efficiently and accurately.
- A learning and professional growth mentality so that new software tools, systems, andprocesses can be adopted quickly and efficiently
- Working knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws.
- Knowledge of and experience working with a variety of local and external IRBs, scientificreview and other research committees, national cooperative group sponsors, industrysponsors, federal and foundation funding organizations, etc.
- Ability to adapt to changing job demands and priorities, remain flexible including workingflexible hours to accommodate research deadlines.
- Availability to work in more than one environment, travelling to various clinic sites,meetings, conferences, etc
|