Job Description

## Please make sure to read the job posting in its entirety as it reflects both the University roles and responsibilities, followed by the specific description.
## _ Department _
2012211 Medicine-Infectious Diseases
## _About the Unit_
## _Job Family_
Research
Responsible for all aspects of research projects and research facilities. Plans and conducts clinical and non-clinical research; facilitates and monitors daily activities of clinical trials or research projects. Directs engineering and technical support activities to develop and maintain tools and computational methods needed to gather and analyze data.
## _ Career Track and Job Level _
Clinical Research
Manages, facilitates, and monitors the daily activities of clinical research and clinical trials. Performs a variety of duties involved in the collection, documentation, analysis and reporting of clinical research and clinical trial data. Manages the strategic, administrative, operational, and financial decisions that impact clinical research and clinical trials conducted across the University.
P1: Performs routine assignments in the entry level to a professional job progression. Typically requires a college or university degree or the equivalent work experience that provides knowledge and exposure to fundamental theories, principles and concepts. Develops competence by performing structured work assignments. Uses existing procedures to solve routine or standard problems. Receives instruction, guidance and direction from others.
## _Role Impact_
Individual Contributor
## _Responsibilities_
The job performs routine assignments related to the documentation, analysis, and reporting of research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.
1) Performs various aspects of clinical research, such as collecting and processing specimens, interviewing subjects, taking vital signs, and contributing to the case report., 2) Analyzes protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics., 3) Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups., 4) Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports., 5) Performs other related work as needed.
*Unit-specific Responsibilities *
1) Coordinate day-to-day management and administration of the study, including team communications, supervision and training of support personnel, financial management / study budgets, protocol development, project implementation and evaluation, milestone tracking, and coordination with subcontract project sites.
2) Manage all aspects of conducting clinical trials including: protocol development for screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
3) Recruit and interview potential study patients with guidance from PI and other clinical research staff.
4) Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
5) Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
6) Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
7) Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.
8) Performs assessments at visits and monitors for adverse events.
9) Organizes and attends site visits from sponsors and other relevant study meetings.
10) Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
11) Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
12) Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
13) Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissio
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