Clinical Research Associate

Merrillville, Indiana, Job Description 
We are looking for an organized, flexible clinical research associate to oversee clinical trials. The clinical research associate will develop and outline trial protocols, establish trial sites, train site staff, and manage Investigational Product (IP) and trial materials. The clinical research associate will manage multiple aspects of the subjects’ welfare. You will conduct regular site visits, generate and distribute internal and external newsletters, prepare final reports, and liaise with interested parties regarding all trial aspects. 
Job Responsibilities:
Creating and writing trial protocols, and presenting these to the steering committee. Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial. Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion. Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects. Ordering, tracking, and managing IP and trial materials. Overseeing and documenting IP dispensing inventory, and reconciliation. Protecting subjects’ confidentiality, updating their information, and verifying IP have been dispensed and administered according to protocol. Conducting regular site visits, coordinating project meetings, and writing visit reports. Implementing action plans for sites not meeting expectations. Liaising with regulatory authorities. Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines. Other tasks and responsibilities as needed. Job Requirements:
Bachelor’s degree in biological science or a related field. 2+ years of experience as a clinical research associate. Knowledge of the pharmaceutical industry, terminology, and practices. Knowledge of FDA regulations and their practical implementation. Strong verbal and written communication skills. Proficient computer skills. Proficient with Microsoft Office Word, Excel, and PowerPoint. Ability to manage and prioritize workload effectively. Available to travel extensively and on short notice, and ability to manage travel schedules, such as flight schedules. Valid driver’s license, proficient driving skills, own reliable transport, and up-to-date car insurance.

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