Clinical Trials Research Associate - Radiology
Clinical Trials Research Associate - Radiology
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Job Description
The University of Iowa Health Care department of Radiology is seeking a Clinical Trial & Data Management Research Associate to perform clinical/health care research activities in support of clinical trials in the Department. Assist in the design development administration and maintenance of protocols and clinical studies. Screen recruit enroll and obtain informed consent for clinical research activities. Participate in the design development and testing of clinical research trial data systems. Manage and organized regulatory documentation.
Position Responsibilities:
- Functions as a member of the Theranostics Research team to plan deliver and evaluate the health care provided to research protocol patients.
- Assist in the development of protocols and clinical studies and provide input into complex research procedures.
- Resolve all monitoring visit issues.
- Develop complex study materials including CRF and centralized monitoring documents.
- Assist physicians in determining eligibility of patients for research protocols.
- Educate study participants on scope of study potential risks and benefits and study requirements for participants.
- Assist in obtaining patient consent to enter protocols and counsel patients and families regarding investigational drug/therapy.
- Oversee operations of clinical research studies including the recruitment coordination and scheduling of subject participation and procedures per protocol requirements.
- Follows study participants; manages and directs collection of data including maintaining records of patient visits/interviews documentation of adverse events and review of medication records. Provides documentation for physician review to ensure patients are screened and treated according to protocol.
- Schedule study related procedures and visits.
- Organize clinic/study procedures follow study participants and manage collection of accurate data in a timely manner keeping data and documentation secure and confidential.
- Communicate with healthcare practitioners agencies and sponsors.
- Provide direction assignments feedback coaching and counseling to assure research outcomes are achieved.
- Validate data query resolution and make recommendations for resolution.
- Maintain records and services provided and work within individual protocol budgets.
- Serve as a liaison to the University Business Office to identify specific patient tests and procedures paid for by study sponsors and assist with questions related to billing for protocol procedures.
- Perform onsite audits of research and clinical data including the design development and implementation of compliance testing criteria and tools.
- Monitor and control specific ethical/compliance issues such as proper consent accurate recruitment materials etc.
- Monitor compliance of regulatory guidelines and proper maintenance of documents.
- Participate in the adverse event reporting process from initial data receipt to final submission.
- Use evaluation data to revise and implement change.
- Maintain effective working relationships with faculty staff students and the public.
- Assists in the preparation of reports to IRB01 Protocol Review and Monitoring Committee and other review committees for multiple clinical research studies; compiles accrual data; reviews and summarizes information for principal investigators and University Institutional Review Board (IRB01; Assists in maintaining documentation of protocols and relevant data followup correspondence and summaries.
- Performs critical analysis of literature relevant to the clinical trials.
- Educates faculty staff and others about clinical research and methods employed in research studies; prepares educational materials for patients and other staff as needed to carry out protocol therapy.
- Selects applies and tests standard methodologies techniques and tools such as manuals forms and questionnaires.
- Attends protocol meetings and other UIHC and Study Sponsor meetings; participates on committees as appropriate.
- Participates in the development of goals for the Theranostics Research program.
The information contained herein is not intended to be an exhaustive list of all responsibilities required of individuals performing this job.
University of Iowa Health Carerecognized as one of the best hospitals in the United Statesis Iowas only comprehensive academic medical center and a regional referral center. Each day more than 12000 employees students and volunteers work together to provide safe quality health care and excellent service for our patients. Simply stated our mission is: Changing Medicine. Changing Lives.
Pay Grade: 4A Benefits Highlights:
- 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
- For more information about Why Iowaclickhere
Education Required
- A Bachelors degree or an equivalent combination of education and experience that is directly related to the duties of the position is required.
Required Qualifications
- Must have the ability to translate adapt and apply knowledge and perform specialized research.
- Considerable 24 years) experience with and participation on clinical trials is required.
- Previous research protocol management experience is required.
- Experience with protocol and medical research data management is required.
- Knowledge of regulatory guidelines and procedures is required.
- Overnight and weekend travel may be required.
- Excellent written and verbal communication skills are required.
Desirable Qualifications
- Prior experience with Radiation and/or Radiology
- Knowledge of research billing.
- Knowledge of CMS clinical trials policies.
- Budget creation and negotiation
- Strong interpersonal skills.
- Strong organizational skills.
- Multiinstitutional study management
- ACRP or SoCRA Certification
Application Process:
To be considered applicants must upload a resume and a cover letter (under submission relevant materials)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. Applications will be accepted until position is filled.
Successful candidates will be required to selfdisclose any conviction history and will be subject to a criminal background check. For additional questions please contact Lori Steffens at
Required Experience:
IC
Employment Type
Full Time
