C. R. Bard, Inc.

Clinical Research Associate II

2 weeks ago
Industry / Category
Medical Device/ Clinical Affairs
Job ID
2017-10856
Career Level
experienced
Division
Bard Peripheral Vascular
Relocation
TBD
US-AZ-Tempe

Overview

Bard Peripheral Vascular – where a tradition of vascular innovation spans decades of focusing on improving the quality of patients’ lives. From C. R. Bard’s first arterial prosthesis developed in 1954, Bard and the division of Bard Peripheral Vascular have demonstrated commitment to innovative medical technology by introducing surgical and interventional devices for peripheral vascular patency, while providing exceptional service and support to surgeons, interventionalists and radiologists. Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. #LI-JC1

Summary of Position with General Responsibilities

The Clinical Research Associate-II (CRA-II) is responsible for conducting the day-to day site management operations associated with the execution of clinical trials. The CRA-II ensures that clinical tasks are being performed in accordance with the study protocol, Bard procedures, ICH-GCP Guidelines, and all applicable regulatory requirements. The Clinical Research Associate-II may also be assigned to monitor at investigative sites on as needed basis.

Essential Job Functions

Under the in-direct supervision of the Project Manager or designee, the CRA-II will:

Support the investigator evaluation and recruitment process;

Perform essential document collection, quality control, review and tracking;

Ensure that Bard and investigator obligations are being met and are in compliance with the study protocol, GCP-ICH Guidelines and applicable regulations;

Support investigative sites in fulfilling their obligations with regard to submissions to local regulatory and IRB/IEC requirements;

Perform study file audits to ensure that the study files are current, accurate and complete;

Track clinical trial management metrics;

Provide support to internal and external teams to meet project specific goals;

Participate in project related meetings;

Assist with investigational product accountability, subject screening/enrollment, case report form retrieval, query distribution to/retrieval from investigative sites;

Verify appropriate documentation and reporting of study events;

As required by certain projects, provide support to resolve internal and external clinical issues;

Assist in the creation and maintenance of clinical project documents, including project plans, monitoring guidelines, data management plans, site study manuals, monitoring visits reports, letter templates, study materials, template log forms and study presentations;

Interact with investigative sites, vendors and other Bard functional areas as secondary project contact for clinical issues;                

Participate in site qualification and site initiation process, including scheduling of monitoring activities with site personnel;

May coordinate and conduct monitoring visits at participating research sites to ensure compliance to the investigational plan, regulations and timely receipt of data, including source document verification, device accountability and writing of monitoring visit reports;

Assist in training of Coordinators;            

      

Basic Qualifications

Two or more years of clinical trial experience;

Strong computer skills;

Proficient in MS Windows based applications;

Working knowledge of GCP-ICH, FDA regulations and current industry practices related to the conduct of clinical trials;

Excellent communication skills; (oral and written)

Strong attention to detail;

Strong interpersonal and organizational skills;

Ability to work independently and manage multiple tasks in a fast paced environment;

Ability to travel up to 50%;

   

Additional Desirable Qualifications Skills and Knowledge

Prior knowledge of GCP-ICH and regulatory requirements for device research and development preferred;

Working knowledge of Electronic Data Capture systems; (EDC)   

Education and/or Experience

BA/BS in a health science field and equivalent combination of training experience; 

Physical Demands

While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear.The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment

Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment.

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