Job Details
Job Overview: Coordinates and manages all components required for an organized multi-disciplinary team approach for the successful participation and completion of clinical research trials in TriHealth. Functioning as an educator, consultant/liaison, and evaluator, the Academic Clinical Research Coordinator strives to coordinate clinical research trials with safety, integrity and efficiency while applying knowledge of good clinical practices. Responsible for working with the PI and study team to determine correct study design, perform literature searches, protocol writing, feasibility assessment. Is the contact for own studies and with all internal and external customers, including external compounding pharmacies. Has knowledge of external pharmaceutical regulations. Maintains study data, performing intermittent analysis. Assists with study feasibility, presentation materials, and development of poster for presentation and / or manuscript for publication. Develops preliminary study budgets. Potentially works with the IACUC and process for CME application. Responsible for marketing and networking. Adheres to the standard operating procedures of the TriHealth Hatton Research Institute. Job Requirements: Bachelor's Degree in Science Equivalent experience accepted in lieu of degree Basic Life Support for Healthcare Providers (BLS) Microsoft Office 2-3 years experience Professional Healthcare Job Responsibilities: Develops processes to facilitate implementation of the research protocol to provide effective and safe medical research to all subjects. Demonstrates the ability to identify potential and/or actual issues which may prohibit the accurate implementation of the research protocol and initiate interventions to avoid protocol violations and /or unsafe practice. Performs initial and ongoing evaluations of research subjects and implements care directed towards optimal outcomes. Plans care for research subjects/family based on clinical consultation, standards of care, optimal outcomes and protocol requirements. Implements and evaluates plan of care. Performs technical skills according to policy and procedure and accepted TriHealth standards. Documents in medical record appropriately. Ensures compliance with IRB/FDA standards and deadlines in the following: notification of subject randomization and enrollment, completing Progress Reports, reporting all deaths and adverse events with study subjects, and facilitating communication between study sponsor and designated TriHealth IRB. Assesses potential subjects for inclusion and exclusion criteria. Keeps Case Report Forms complete and thorough using the IRB and FDA standards. Supports hospital staff in complying with research protocols and works to minimize the impact on their workload. Keeps queries and protocol violations that can be controlled to a minimum. Responds appropriately and accurately to all queries in a timely fashion. Maintains accurate and detailed follow up schedules to assure meeting regulatory time points. Maintains study data and performs inermittent analysis Responsible for working with the PI and study team to determine correct study design, perform literature searches, protocol writing and development, feasibility assessment. Serves as the contact for all internal and external customers, including external compounding pharmacies, with knowledge of external pharmaceutical regulations. Maintains study data and performs analysis; and assists with study presentation materials, and developing posters for presentation and / or manuscript for publication. Develops preliminary study budgets. Potentially works with the IACUC and process for CME application. Other Job-Related Information: Working Conditions: Climbing - Rarely Concentrating - Frequently Continous Learning - Frequently Hearing: Conversation - Occasionally Interpersonal Communication - Consistently Lifting