BD (Becton, Dickinson and Company) Sr. Clinical Research Associate in Tempe, Arizona
Job ID: 2018-12231
Career Level: experienced
Location: Tempe,Arizona,United States
The Sr. Clinical Research Associate (Sr. CRA) is responsible for directing the day-to day management operations associated with the execution of clinical trials.
Summary of Position with General Responsibilities:
The Sr.CRA ensures that clinical tasks are being performed in accordance with the study protocol, Bard procedures, ICH-GCP Guidelines, and all applicable regulatory requirements. The Sr. CRA will also be assigned to monitor at investigative sites on as needed basis. Under the direction of the Project Manager the Sr. CRA may be assigned as the primary vendor contact.
Essential job Functions:
In conjunction with the Project Manager the Sr. CRA will:
Support the development of the study protocol/case report forms, investigators brochure, clinical instructions for use, clinical reports and study documents;
Create and maintain clinical project documents, including project plans, monitoring guidelines, data management plans, study manuals, monitoring visit reports, letter templates and study presentations;
Interacts with investigative sites, vendors and other functional areas as primary project contact for clinical issues;
Conduct on-site clinical monitoring/quality activities to:
Ensure that clinical staff assigned to specific clinical research projects complete tasks in accordance with the project agreements, Bard procedures and applicable regulations (ICH-GCP, HIPAA, CFR, ISO);
Document and report non-compliance in a timely manner;
Ensure that all clinical events are reported appropriately;
Conduct investigational product accountability, subject screening/enrollment assessments, case report form monitoring/retrieval, and query resolution and ensure compliance with core lab requirements and submission of data for analysis.
Mentors less experienced CRAs
Provides regular clinical status information to team members and the Project Manager;
Recommend and implement enhancements to clinical systems, guidelines, and processes;
Review work produced by the clinical team; (trip reports, correspondence, tracking reports, etc)
Evaluate metric data to identify process improvements;
Coordinate and review clinical tasks;
Ensure that the monitoring team receives appropriate project and therapeutic training;
Assists in the development and implementation of standardized processes and procedures for conducting clinical research
A minimum of 3-4 years experience monitoring and managing investigational sites
Prior experience leading professional staff in a clinical research environment preferred
Strong computer skills
Proficient knowledge of FDA regulations regarding device research and development is required
Excellent communication skills (oral and written)
Strong attention to detail
Strong interpersonal and organizational skills
Ability to work independently, manage multiple tasks and personnel in a fast paced environment
Ability to travel up to 40%
Education and/or Experience:
BA/BS in Health Science Field or equivalent combination of training and experience
Three years in the Health Science Field
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.
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.
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