University of Iowa Health Care Department of Internal Medicine, Division of Infectious Diseases is seeking a Clinical Trial & Database Management Research Associate to support, conduct and manage clinical trials to deliver and evaluate research protocols.Key areas of responsibility include protocol development/management and clinic/study responsibilities; research/clinical activities, subject recruitment and enrollment, data collection and monitoring; regulatory guidelines and documents; human resources/leadership; and financial responsibility.Develop, prepare and monitor budgets and prepare financial reports.Assist in research trial enrollment, processing and orientation.Obtain, prepare and assemble and distribute educational and promotional program materials.Manage supply inventory and shipping of specimens for clinical trials.Duties to include:
Protocol Development/ Management and Study Responsibilities:
Assist in the design, development, execution, administration and maintenance of protocols and clinical studies.
Assist in grant-related clinic and study design and protocol development and provide input into descriptions of complex research procedures.
Oversee CRF development.
Review query reports.
Resolve all monitoring visit issues.
Perform and monitor randomizations.
Develop complex study materials.
Serve as liaison to local health care practitioners, agencies and sponsors.
Supervise activities of participants.Coordinate clinic visits for subjects, making sure the clinic is properly supplied to carry out the protocol procedures.
Research/Clinical Activities; Subject Recruitment and Enrollment:
Screen, recruit, enroll and obtain informed consent for clinical trials.
Oversee the recruitment of subjects and scheduling of trial- and grant-related clinic procedures.
Education study participants on scope of study, potential risks and benefits, possible alternatives and study requirements for participants.
Design brochures, application materials, evaluation forms and educational material related to patient care, research and findings.
Relay information to principal investigator and verify student participant eligibility.
Data Collection and Monitoring:
Participate in the design, development and testing of clinical research and clinic-related data systems.
Validate data, query resolution and make recommendations for resolution.
Revise and implement change in data collection.
Regulatory Guidelines and Documents:
Manage and organize regulatory documentation from sites and regulatory authorities.
Prepare regulatory submissions.
Perform on-site audits or research and clinical data.
Monitor compliance of regulatory guidelines and proper maintenance of documents.
May recommend corrective action for reportable events.
Counsel and provide information specific to the grant-related clinical and research programs. Prepare research materials for IRB, CRC, P and T committee, including safety reports, renewals, and protocol modifications.
Serve as liaison to specialists, granting agencies, research programs and organizations interested in program development and/or participation.Represent the site in various investigational meetings
May provide functional and/or administrative supervision.
Mentor new staff under direction.
Develop training and supervise the work activities of student employees and functional supervision of study nurses, the clinical research center staff, laboratory personnel, and other assigned support staff.
Responsible for Workflow related functions (financial electronic transaction routing).Oversee expenditures and make payments on grants.
Prepare special and periodic financial reports for the HIV Program (HRSA) Grant administration - including quarterly financial reports, management of clinical charges, reimbursement, patient spending caps, discounts, etc.
Manage supply inventory and shipping of specimens for clinical trials.
Percent of Time: 100%
Salary: $ 42,038- Commensurate
Regular salaried position located in Iowa City, Iowa
Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans
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The University of Iowa offers a generous benefits package, including paid vacation and paid sick leave. Complete information regarding the full benefits package may be viewed at: .
A Bachelor's degree or an equivalent combination of education and experience is required.
Excellent written and verbal communication are required.
1 year of administrative experience and experience working with programmatic budgets is required.
Proficient in Microsoft Word and Excel is required.
Proficient in Access and CareWare is desirable.
Experience in direct patient interactions, HIV and other infectious diseases are desirable.
A Master's degree is desirable.
6 months experience in public speaking, technical writing or teaching is desirable.
Supervisory experience desired.
Application Process: In order to be considered, applicants must upload a resume, cover letter and 3 references that clearly address how they meet the listed required and desired qualifications of this position.
Job openings are posted for a minimum of 14 calendar days.
Successful candidates will be subject to a criminal background check.
The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran.
Internal Number: 20001032_1578412407
About University of Iowa
With over 31,000 students, the University of Iowa is one of the nation's top public research universities, a member of the Big Ten conference and the Association of American Universities. The University of Iowa is composed of eleven colleges and is known around the world for its balanced commitment to the arts, sciences, and humanities. It is home to one of the nation's largest academic medical centers and the pioneering Iowa Writers' Workshop. The University of Iowa promotes work/life integration and is located in the casual yet cosmopolitan environment of Iowa City, widely recognized as one of the country's most livable communities.