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TriHealth · 1 day ago

Clinical Research Coordinator

Montgomery, OH

Full-time

Onsite

Entry, Mid Level

TriHealth is dedicated to providing quality healthcare and is seeking a Clinical Research Coordinator to manage and coordinate clinical research trials. The role involves ensuring compliance with safety standards, coordinating between study teams, and evaluating research subjects to achieve optimal outcomes.

Health CareService IndustryWellness

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