Clinical Research Coord II

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, bi-annual and tri-annual required training. Submit protocol registration and results information to ClinicalTrials.gov, a web-based 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. 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 r to ensure billing compliance. Responsible for monitoring and maintaining daily fiscal activities for projects, including approving research-related 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 patient-related charges and per-patient 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 bi-annual institutional billing and compliance training. Provide daily review in EPIC of potential research-related charges. Maintain a tracking log with all per-patient project-related billable charges and work closely with Department fiscal managers to ensure appropriate billing and invoices received from facility for research-related charges. Ensure all research-related 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 third-party payors were not paid with study funds. Provide project tracking log, study budget, agreements, protocol, contracts and amendments, and IRB documentation to auditors. Work with the PI and provide monthly report and annual reviews or other agency-required 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 multi-disciplinary 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 follow-up data from hospital charts, assessments, and clinic visits. Coordinate with patient coordinators/office staff regarding follow-up 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 patients or families regarding research status, participation, and plan, or any questions they may have. Monitor daily patient’s ability to consent for self if Informed Consent is obtained by LAR. Correspond with referring physicians regarding Inclusion/Exclusion criteria of research candidates.

Data Management
Responsible for subject enrollment and patient follow-up 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 sponsor-requested data clarification and query forms in a timely manner.

Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.

Master’s 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.