This position will provide clinical support for the Amyloidosis Research Team located within the Department of Pathology and Laboratory Medicine at IU School of Medicine. Duties include, but not limited to, initiate, conduct, complete, and report clinical studies/trials in clinical evaluation of the testing within the Amyloidosis Research studies. Assist in the conduct and implementation of clinical research in Pathology and Laboratory Medicine. Participate in the initiation; monitoring, completion, and reporting of routine to moderately complex clinical studies in accordance with Standard Operating Procedures (SOP) and Good Clinical Practices (GCP). Develop solutions to complex problems that impact the timely and accurate conduct of clinical research. Clinical scheduling and assisting with faculty publications.
This position will be expected to conform to all established protocols, policies, and procedures established by the University and the Department. If necessary, this position will also set new protocols, policies, and procedures. Incumbent will be responsible for maintaining study data and files in compliance with university rules, regulatory agencies, and clinical research best practices. Must be able to utilize analysis to provide management with interpretations. The incumbent will also monitor data integrity and will participate in system problem resolution. This position is key to the viability of the department; poor decision making will result in significant consequences to the department.
Primary Duties and Responsibilities:
* Evaluate feasibility of protocols. Collect and evaluate the research data and submit data reports including assessment of any adverse event. Review and critically assess adverse events with PI and submit to clientele.
* Extract data from source documents, develop database for specimen requirements, and complete data entry into electronic data system. Complete Case Report Forms (CRF) or database entries. Ensure compliance with research schedules and data submission. Prepare and document protocol deviations as required by client and IRB. Develop tools for collecting and maintaining research data and documents to ensure compliance of federal guidelines for clinical research.
* Prepare and submit Institutional Review Board (IRB) documents. Prepare regulatory documents for clients. Schedule study-related meetings and training sessions for staff. Provide instruction to study team for specific study assignments. Educate staff regarding scientific aspects of research. Train ancillary staff regarding clinical research. Develop worksheet for "Standard of Care" versus study specific procedures. Monitor team compliance with required research procedures and GCP standards.
* Ensure proper collection, processing, shipment of specimens, research and documentation of IHC Laboratory specimens. Communicate with laboratory, Principal Investigator, and sponsor regarding laboratory findings.
* Compose and submit continuing review/amendments /close out information. Schedule and prepare for monitor visits. Prepare and respond to Sponsor or FDA audits and queries. Audit internal documents for accuracy and compliance with good clinical practice. Archive documents for research per government and institutional requirements.
* Maintain current knowledge of regulatory affairs and/or issues. Maintain a high level of expertise through familiarity of clinical literature and/or attending continuing education classes, conferences, seminars, and project team meetings.
* Monitor/update clinical schedule and assist with faculty publication.
Note: This position is not eligible for Visa sponsorship.
Bachelor's degree in science or a health-related field and one year of health-related/research experience; or associate's degree in Allied Health professions/bachelor's degree in other disciplines and three years of health-related/research experience or two years of clinical research experience.
Familiarity with electronic data capture systems. Basic computing skills and knowledge of MS Office. Detail oriented with strong organizational skills. Ability to track and perform multiple tasks. Strong communication and interpersonal skills. Strong analytical skills to make quantitative and qualitative observations. Ability to work under tight deadlines. Ability to quickly and effectively deal with unplanned emergent issues. Ability to deal with constant interruptions with repeated distractions. Ability to integrate new information into practice. Knowledge of state, federal, and program regulations. Ability to handle confidential information discreetly. Ability to work independently with minimal supervision.
Clinical Research Certification (ACRP or SOCRA).
Working Conditions / Demands
Equipment utilized: Professional equipment such as computers, faxes, scanners, copy equipment. Study related equipment/instrumentation and basic laboratory equipment such as pipettes, centrifuges, vortexes, etc.
Physical Requirements: Sitting for long period of time, reading and analyzing data.
Salary Plan: TE
Salary Grade: 09
Job Function: Health Services
This posting is scheduled to close at 11:59pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
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