The Clinical Resaerch Specialist will assist in the conduct and implementation of clinical research. Participate in the initiation, monitoring, completion, and reporting of routine to moderately complex clinical studies in accordance with SOP and GCP.
Primary Responsibilities Include:
Follow up/ Schedule study subjects. Perform study interviews. Conduct study-related clinical procedures and interventions. Ensure proper collection, processing, and shipment of specimens. Review serious adverse events. Collaborate with physicians and other care givers in the collection of clinical data. Monitor for protocol compliance. Prepare for and manage monitor visits. Understand and follow IRB guidelines. Educate staff regarding scientific aspects of the study.
Extract data from source documents. Complete Case Report Forms (CRF) or database entries. Audit for accuracy and correct CRFs. Resolve sponsor queries. Provide/create source documentation tools for subjects' charts/records.
Ensure proper collection, processing, shipment of specimens, and documentation. Communicate with laboratory, Principal Investigator, and sponsor regarding laboratory findings.
Order and receive drug/device supplies. Dispense drug/device supplies (calculate dosage as needed). Maintain files of drug/device dispensation, compliance and return.
Participate in the evaluation of research protocols including study design and risk to target population. Access and extract information for protocol development. Assess target population/availability. Assist in determining staff, facility and equipment availability.
Assist with preparing and submitting Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary). Prepare regulatory documents for sponsor.
Schedule study-related meetings and training sessions. Provide instruction to study team for specific study assignments.
Identify potential subjects from review of existing protected health information based on Inclusion/Exclusion criteria. Recruit subjects according to IRB/protocol approved methodologies; consent subjects including discussion of treatment and intervention alternatives and ensure that Informed Consent forms are properly signed before the start of the study. Determine appointments per protocol. Schedule subjects for appointments. Perform subject interviews and assessments at study visits for data required by protocol. Assess and ensure subject safety throughout participation in trial.
Record and document protocol deviations. Communicate with PI and sub-investigators about changes in the trial. Review incoming subject adverse event (SAE) information and assist PI in making submission determination of SAEs. Maintain follow-up to determine resolution of adverse event. Capture and record adverse events data. Compose adverse event reports for oversight agencies.
Audit documents and pertinent files and prepare for storage. Archive documents for study per sponsor/government/institutional requirements. Evaluate team effort at site. Document "drop outs" (e.g., causes, contact efforts).
Bachelor's degree in science or health-related field plus one year of experience; OR bachelor's degree in any other field/associate's degree in Allied Health professions and three years of health-related experience or two years of clinical research experience.
Respiratory therapist licensure.
Strong computer, telephone, and math skills. Ability to calculate medication dosages for pediatric patients. Ability to effectively communicate and exchange information.
Working Conditions / Demands
Equipment utilized: Computer, Microsoft Office software, fax machines, copiers, and telephone. Medical gases, suction equipment. May be required to give/provide medication to pediatric patients. May be required to utilize oxygen, oximeters and other study specific equipment.
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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Founded in 1820, Indiana University is the state’s public university system, comprised of two core campuses—IU-Bloomington and IUPUI—and six regional campuses located throughout the state. Combined, the total student population is more than 114,000 undergraduate, graduate and professional school students. IU is one of the largest employers in the state, with over 20,000 faculty and staff. Indiana University is an equal employment and affirmative action employer and a provider of ADA services. Diversity and inclusion remains a core commitment to IU’s mission to cultivate an educational environment that supports equal access, participation and representation on all of its campuses and that provides educational and career opportunities for all.