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Sr Clinical Research Associate
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Job ID
26398
Location
USF Health
Full/Part Time
Full-Time
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Regular
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Position Details
Dept. Number/Name: 0-6118-000 / Dept. Of Psych & Behavior
College Division: USF Health-Morsani College of Medicine
Salary Plan: Administrative (Grant-Funded)
Job Code/Title: 4435 / Sr Clinical Research Associate
Hiring Salary/Salary Range: $72,000 - $80,000
Position Number: 00044383
ORGANIZATIONAL SUMMARY:
The Department of Psychiatry and Behavioral Neurosciences pride itself on engaging our local community through clinical services, innovative research, and education.  Founded in 1987, the Department has received national and international recognition and support for its research and innovative approaches to treatment.
The Department of Psychiatry and Behavioral Neuroscience's mission is to educate health care practitioners about mental, addictive, and behavioral disorders, advance scientific knowledge about the nature, causes, and treatment of these conditions, and provide exemplary models of clinical care in order to benefit the health and well-being of the people of Florida.  For more information, please visit: http://health.usf.edu/medicine/psychiatry/
POSITION SUMMARY:
This position oversees the daily operations of the clinical research division at the Byrd Alzheimer's Institute in the Department of Psychiatry. They train and manage the teams assigned to various projects and oversee the compliance, reporting and administration of clinical research activities under the Principal Investigator(s). Responsibilities include direct supervision of 7 research support staff. This position works closely with the Division Director, Department Administrator, and Assistant Director in implementing the mission and developing strategic planning for the division's clinical research portfolio. This position is grant funded.
RESPONSIBILITIES:
• Maintain clinical research site at the Byrd Alzheimer's Institute and oversee daily operations of clinical research division. Responsibilities include monitoring equipment calibration, coordinating research schedules, departmental ordering, advertising, and administering study portals. Oversee compliance including biomedical waste certifications, HIPAA, CITI (human subjects protection), IATA (shipping and transporting hazardous materials) and training and ensuring staff are following appropriate regulations and policies. Responsible for direct supervision of all clinical research staff. Reports to and liaises with director of clinical research. Trains and manages staff.
• Maintains all regulatory binders and documents according to sponsor and FDA guidelines. Trains staff on compliance requirements. Ensures timely submission of Institutional Review Board (IRB) documents, modification requests, sponsor reports, annual reports, and other documents to internal offices and external agencies in accordance with guidelines and regulations. Manages all regulatory, compliance, administrative, and internal and external reporting. Maintains document and record controls, oversees adherence to data safety monitoring, adverse reaction reporting and oversees implementation and compliance to policies, procedures, and protocols.
• Oversees study startup and overall financial administration including budget negotiations and development, initial regulatory and Institutional Review Board (IRB) submissions, development of Confidential Disclosure Agreements (CDAs), surveying and qualifying new sites using various assessment tools; coordinating with the Office of Clinical Research on Clinical Trial Agreements (CTAs). Reviews study budgets, verifies and approves expenditures, Processes and reviews invoices, reconciles expenditures, develops budget projections on multiple accounts.
• Conducts study visits according to standardized research protocols. Presents informed consent to potential research subjects and study partners; collects signatures and other information. Data entry of collected research information. may include some recruitment efforts including public speaking at various venues and audiences. Drafts reports for publication or public dissemination. Acts as a consultant or liaison to external entities as required. Reviews data quality and completeness.
• Other duties as assigned.
POSITION QUALIFICATIONS:
MINIMUM :
• This position requires a Bachelor's degree in a field directly related to the program responsibilities and three years of professional experience; or Master's degree in an area of specialization appropriate for the program and one year of professional experience.
PREFERRED:
• Clinical trials experience; certification for Human Subjects protections training and Good Clinical Practice (GCP); experience administering cognitive and/or caregiver rating scales;  experience in contract/budget negotiations and IRB submission
Are you interested in clinical job opportunities with the USF Health Care working for University Medical Service Association, Inc. (UMSA)?  Visit https://usfpgcareersource.health.usf.edu/ for more information.
USF Health
Information for Applicants
This position is subject to a Level I criminal background check.
Job Opening Number: 26398
Posting Date:  1/15/2021
Posting End Date: 1/29/2021
How To Apply
Click on the Apply Now button.  When applying to an opening you will have the opportunity to upload a cover letter and resume.
Apply online by completing the required information and attaching your cover letter and resume. Please include your experience as it relates to the qualifications stated above.  YOUR COVER LETTER AND RESUME, PLUS ANY OTHER REQUESTED MATERIAL, MUST BE IN ONE ATTACHMENT. Only online applications are accepted for this position.
Click here for additional tutorial information.
Equal Employment Opportunity
USF is an equal opportunity, equal access academic institution that embraces diversity in the workplace.The University of South Florida does not discriminate on the basis of sex and prohibits sexual harassment. Any person may report sex discrimination, including sexual harassment (whether or not the person reporting is the person alleged to be the victim of conduct that could constitute sex discrimination or sexual harassment), in person, by mail, by telephone, or by electronic mail, using the contact information listed for the Title IX Coordinator. Reports may be made at any time either online or directly to the University's Title IX Coordinator.
Work Location
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USF - Health
USF - Tampa Campus
About USF
The University of South Florida is a high-impact global research university dedicated to student success. Over the past 10 years, no other public university in the country has risen faster in U.S. News and World Report's national university rankings than USF. Serving more than 50,000 students on campuses in Tampa, St. Petersburg and Sarasota-Manatee, USF is designated as a Preeminent State Research University by the Florida Board of Governors, placing it in the most elite category among the state's 12 public universities. USF is a member of the American Athletic Conference.
Working at USF
With more than 16,000 employees at USF, the University of South Florida is one of the largest employers in the Tampa Bay region.  At USF you will find opportunities to excel in a rich academic environment that fosters the development and advancement of our employees.  We believe in creating a talented, engaged and driven workforce through on-going development and career opportunities. We also offer a first class benefit package that includes medical, dental and life insurance plans, retirement plan options, tuition program and generous leave programs and more.
To learn more about working at USF please visit: Work Here. Learn Here. Grow Here .
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