Clinical Research Coordinator

Description

Under direction of the Principal Investigator (PI) and the CTU/CRS Manager, the employee is to perform research activities directly related to HIV clinical trials in the Center for Clinical AIDS Research and Education (CARE Center) including but not limited to the AIDS Clinical Trials Group (ACTG), HIV Prevention Trials Network (HPTN), HIV Vaccine Trials Network (HVTN), and COVID19 Prevention Trials Network (CoVPN). The incumbent will be directly responsible for assisting with fast-paced implementation of HIV trials; assigned start up and closure of clinical research studies, participant registration, randomization, compliance, participant recruitment, enrollment, data management and education as related to each protocol. Document signs, symptoms and other changes for reporting to PIs as appropriate with research participants; assist in report preparation for IRB, IBC, CTSI/CTRC, radiology and other ancillary departments and/or committees. Participate in quality assurance activities for studies across the research unit. Interact with study monitors regarding protocol management and resolution of study queries. Work with outreach team in expanding recruitment efforts for HIV trials. Assist in drafting general standard operating procedures for CARE Research, as well as study-specific standard operating procedures, source documents, and forms. Assist with all aspects of preparation for and conduct of regulatory audits. Other tasks as assigned.

Hourly salary range: $38.19 - $61.45

Qualifications

Required:

• Bachelor's degree in related area and/or equivalent combination of education and experience.

• Minimally 2+ years of previous study coordination or clinical research coordination experience

• 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

• 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, 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-to-understand manner.

• Ability to adapt to changing job demands and priorities, remain flexible including working flexible hours to accommodate research deadlines.

• 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.

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