BD (Becton, Dickinson and Company) Clinical Research Associate II in New Hope, Minnesota

Job ID: 2018-11325

Career Level: experienced

Division: New Hope MN/Lutonix

Relocation: Yes

Location: New Hope,Minnesota,United States

Overview:

The Clinical Research Associate II (CRA II) is responsible for conducting the day-to-day management of activities associated with the execution and monitoring of high quality clinical trials for Lutonix products. The CRA II ensures that clinical tasks are being performed in compliance with applicable regulatory standards, Good Clinical Practices, and company policies and procedures.

Summary of Position with General Responsibilities:

•Assist in the planning and execution of clinical studies ensuring that deliverables are completed on time and within budget

•Create and manage reports that detail the clinical study progress such as subject screening and enrollment, data collection, documentation of adverse events, and payments

•Assist with the development and management of study-related documents and materials such as investigational plans, case report forms, study manuals, monitoring plan, informed consents, websites, recruitment materials and other study related tools

•Participate in site qualification and site initiation process, including review of required site documentation

•Conduct training of investigators and coordinators

•Coordinate and conduct monitoring visits at investigative sites to ensure compliance to the investigational plans, regulations, and timely receipt of data, including source document verification, device accountability, and writing of monitoring visit reports

•Verify appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements

•Management of investigative sites to ensure sponsor support of trial activities and oversight of site compliance

•Assist with the development and implementation of site corrective actions as needed to address any noncompliance issues

•Assist in planning, preparing, and presenting materials for investigator and coordinator meetings

•Assist with vendor management to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work

•Participate in regular project team meetings

•Develop and maintain current working knowledge of the disease state & product

•May assist clinical manager by providing input to sections of clinical reports for FDA (510(K), IDE/PMA) and abstracts/manuscripts

Basic Qualifications:

•BA/BS or equivalent medical / industry experience

•Minimum of 2+ years experience directly supporting Clinical Research

•Strong computer skills with a proficiency with MS Windows based applications

•Strong working knowledge of Good Clinical Practices (GCP), FDA regulations, ISO 14155, and current industry practices related to the conduct of clinical trials

•Excellent communication skills (oral and written)

•Strong organizational skills and able to manage multiple tasks

•Ability to work independently

•Previous experience with peripheral vascular devices preferred

•Previous experience with EDC systems preferred

•Ability to work effectively on cross-functional teams preferred

•Demonstrated ability to work effectively on cross-functional teams

•Valid driver’s license required

•Able to travel 20% on average and up to 50% during peak periods

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status