Clinical Research Coordinator

TriHealth•Montgomery, OH

14h

About The Position

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 Clinical Research Coordinator strives to coordinate clinical research trials with safety, integrity and efficiency while applying knowledge of good clinical practices. Coordinates Phase II thru IV trials from initial sponsor contact for site selection, study preparation and execution to study completion and close-out. Responsible for marketing and networking with sponsors. Determines protocol feasibility and some budgetary issues. Adheres to the standard operating procedures of the TriHealth Hatton Research Institute.

Requirements

Bachelor's Degree in Biological Science; Hard Sciences, Psychology, Sociology
Equivalent experience accepted in lieu of degree
Basic Life Support for Healthcare Providers (BLS)

Responsibilities

Demonstrates the ability to develop 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.
Demonstrates the ability to coordinate necessary activities between Study Coordinators and the Principal Investigator.
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.
Complies with all IRB/FDA requirements in study submission.
Assures compliance with IRB/FDA standards and deadlines in notification of subject randomization and enrollment.
Assures compliance with IRB/FDA standards and deadlines in completing Progress Reports.
Assures compliance with IRB/FDA standards and deadlines in reporting all deaths and adverse events with study subjects.
Assures compliance with IRB/FDA standards and deadlines in 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.
Demonstrates knowledge of available studies, screening potential patients for eligibility, guiding physicians and staff in needed timetables for capturing protocol related data points.
Attends trainings required by sponsoring organizations for specific protocols and/or attends meetings related to the initiation or on-going progress of a sponsored clinical trial.
Acts as the point person for audit staff coming into institution for a review prepares a written response with a plan of action to any major/minor deficiencies.