Primary Duties and Responsibilities
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The Clinical Research Coordinator supports the operational management of clinical research activities throughout the study lifecycle, including design, start-up, conduct, and closeout. This role is responsible for implementing and managing research activities for one or more studies, prioritizing tasks to meet required deadlines. The Coordinator plans and organizes study activities to ensure compliance with study protocols and applicable regulations, including institutional policies, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP). The role involves close collaboration with the Principal Investigator, ancillary departments, central research teams, sponsors, and external institutions to support compliant study conduct, financial management, and adequate staffing.
Hourly Salary Range: $36.37 - $58.52
Job Qualifications
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Required:
- Bachelors Degree or 1-3 years of previous study coordination or clinical research coordination experience
- Strong verbal and written communication skills along with strong interpersonal skills to effectively establish rapport, and build collaborate relationships.
- Strong organizational capabilities to organize multiple projects and competing deadlines for efficiency and cost-effectiveness.
- Working knowledge of the clinical research regulatory framework and institutional requirements.
- Analytical skills sufficient to work and solve address problems and identify solutions with reasoned judgment.
- Ability to adapt to changing job demands and priorities; work flexible hours to accommodate research deadlines.
- Ability to respond to situations in an appropriate and professional manner.
- Ability to concentrate and focus in a work environment that contains distracting stimuli and competing deadlines.
- Ability to be flexible in handling work delegated by more than one individual.
- Typing and computer skill/ability including word-processing, use of spreadsheets, email, data entry. Ability to navigate numerous software programs and applications.
- Ability to handle confidential material information with judgement and discretion.
- Mathematical skills Sufficient to prepare clinical research budgets, knowledge of math ability and knowledge of clinical trials research budgeting process to assist with the preparation of clinical trial budgets.
- Working knowledge of FDA Code of Federal Regulations (CFR) and ICH Good Clinical Practice (GC) for clinical research.
- Be available to work in more than one environment, travel to meetings, off-site visits, conferences, etc.
As a condition of employment, the final candidate who accepts an offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; or have filed an appeal of a finding of substantiated misconduct with a previous employer.