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Description

The Senior Clinical Research Coordinator contributes to the overall operational management of clinical research/trial/study activities from design, set up, conduct, through closeout. The position has responsibility for the implementation of research activities 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 to ensure adherence to the study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP). The Senior Study Coordinator collaborates with the Principal Investigator (PI), ancillary departments, central research infrastructure teams, sponsors, institutions, and other entities 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 a general overview of duties and tasks performed by Clinical Research Coordinators. Performance of duties and tasks will vary based on the department operations, the type of study and scope of service.

Qualifications

Required:

Minimum of 4+ years of experience in a clinical research setting

Interpersonal skills to effectively communicate information in a timely, professional

manner and establish and maintain cooperative and effective working relationships with

students, staff, faculty, external collaborators and administration and to work as a

member of a team.

Ability to effectively communicate to and interact with patients in a compassionate and

kind manner.

Ability to set priorities and complete ongoing tasks with competing deadlines, with

frequent interruptions, to meet the programmatic and department needs, while complying

with applicable University policies and federal and state regulations.

Analytical skills to assess clinical research protocols and regulatory requirements, define

problems, formulate logical solutions, develop alternative solutions, make

recommendations, and initiate corrective actions.

Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload

environment.

Organization skills to create and maintain administrative and regulatory files effectively

as well as independently balance the various tasks to ensure deadlines are met.

Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to

perform daily tasks efficiently and accurately.

A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently.

Knowledge of and experience working with a variety of local and external IRBs, scientific

review and other research committees, national cooperative group sponsors, industry

sponsors, federal and foundation funding organizations, etc.

Strong verbal and written communication skills to effectively establish rapport, building

collaborative relationships, and communicate complex concepts and ideas in an easy-tounderstand

manner.

Ability to adapt to changing job demands and priorities, remain flexible including working

flexible hours to accommodate research deadlines.

Ability to handle confidential information with judgement and discretion. All Required

High degree of concentration and focus in a work environment that contains distracting

stimuli, competing deadlines, and work delegated by more than one individual.

Availability to work in more than one environment, travelling to various clinic sites,

meetings, conferences, etc...

Strong knowledge of and experience working with a variety of local and external IRBs,

scientific review and other research committees, national cooperative group sponsors,

industry sponsors, federal and foundation funding organizations, etc.

Strong knowledge of clinical research concepts, policies and procedures, and human

safety protection regulations and laws.

Ability to think creatively to develop solutions affecting the full team. All Required

Experience with FDA processes and procedures.

Sufficient experience and knowledge of clinical trials budgeting processes to manage the

preparation of clinical trials budgets -

Bachelor's degree required, Master's degree preferred

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