Clinical Research Coordinator II Division of Population Health Science

Clinical Research Coord II Division of Population Health Science

Bachelors degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

Regulatory & Budget Coordination

Must be knowledgeable in institution IRB and Western IRB policies procedures and standards of conduct. Assist PI in managing and following all guidelines related to prospective retrospective Emergency Use Only and Humanitarian Device Exemption Studies. Assist the PI in providing research compliance and oversight related to all studies. Oversees the IRB process including the creation coordination and/or development of research protocols informed consents and introductory questionnaires for IRB submission. Attend Investigators meetings as necessary. Must complete annual biannual and triannual required training. Submit protocol registration and results information to a webbased data entry system that provides public access to a directory of federally and privately supported clinical trials that test the effects of drugs biologics devices and procedures on medical diseases and conditions per institution and government requirements.
Assist PIs with coordinating and developing research project budgets and calculating personnel and facilities costs with the PI. Create fiscal research accounts by working closely with facility lab Investigational Drug Pharmacy Radiology Cardiovascular Lab and clinics. Forecast expenditures for the entire project budget period to ensure that the project is neither overspent nor inappropriately underspent. Manage assigned fiscal research accounts and collaborate with the facility in order to ensure billing compliance. Responsible for monitoring and maintaining daily fiscal activities for projects including approving researchrelated charges payments to patients payments to facilities and ensuring that expenditures comply with project guidelines. Work with clinical billing staff to ensure billing is appropriate. Create and submit project invoices to sponsoring agencies for patientrelated charges and perpatient enrollment fees. Must be knowledgeable in policies procedures and standards of conduct that promote adherence to applicable laws as well as to the requirements of the facility institution federal state and private funding agencies. Must complete annual and biannual institutional billing and compliance training. Provide daily review in EPIC of potential researchrelated charges. Maintain a tracking log with all perpatient projectrelated billable charges and work closely with Department fiscal managers to ensure appropriate billing and invoices received from facility for researchrelated charges. Ensure all researchrelated charges are settled prior to study closure. Review all payments to ensure that they were made by the appropriate source and that all services billed to research participants and their thirdparty payors were not paid with study funds. Provide project tracking log study budget R99 agreements protocol contracts and amendments and IRB documentation to CTC auditors. Work with the PI and provide monthly report and annual reviews or other agencyrequired reports (as needed) such as CMS the Department of Defense and private agencies. Keep the PI apprised of the fiscal status of their projects.

Research Coordination

Assist PIs with developing and analyzing clinical research activities for participants and assist in making changes in processes and procedures as necessary. Oversee patient enrollment and provide clinical care to participants enrolled in clinical trials under the direction of the PI as it relates to study procedures. Schedule procedures especially those involving multidisciplinary efforts. Provide education to patients and families as related to the study. Reinforce patient and family education as related to their study responsibilities. Examine medical records for medications vital signs past medical history past surgical history etc. Access medical records from HIS EPIC LCR and Data Support Services in order to analyze results on diagnostic studies labs clinic notes operative reports etc. Collect followup data from hospital charts assessments and clinic visits. Coordinate with patient coordinators/office staff regarding followup appointments for study patients. Inform the PI of Serious Adverse Effects (SAE) and obtain signatures on IRB/sponsor SAE reports. Track disbursements and payments of invoices. Communicate with research patient or family regarding research status participation and plan or any questions they may have. Monitor daily patients ability to consent for self if Informed Consent obtained by LAR. Correspond with referring physicians regarding Inclusion/Exclusion criteria of research candidates.

Data Management Responsible for subject enrollment and patient followup for projects. Maintains/collects data for study patients accurately and completely. Reviews patient enrollment concerns with PI and makes any necessary changes based on PI recommendations. Maintains multiple electronic databases based on individual projects. Submits monthly patient screening and prescreening information to multiple sources. Responsible for completing sponsorrequested data clarification and query forms in a timely manner.

Other duties as assigned

$46000 $57000

Bachelors degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

Masters Degree or higher. Knowledge regarding IRB procedures forms and approval process. Ability to communicate information verbally and in writing. Ability to establish and maintain effective working relationships with others. Ability to type letters memorandums and other standard business documents in correct format. Ability to operate general office equipment. Ability to communicate with patients their parents and family. Knowledge of topical wound care wound assessments and dressing application.

In order to be considered you must upload your cover letter and resume.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.