Position Description

The Clinical Research Associate (CRA) assists the study manager and has the responsible for managing and meeting the milestones of a clinical study in compliance with applicable clinical and regulatory standards and in alignment with Medtronic business needs. The role focuses on assigned areas of clinical study management including the design, initiation, management, monitoring and closing of clinical studies.

Position Responsibilities

* Follow all work/quality procedures to ensure quality system compliance and high quality work.
* Responsible for or assists with writing plans, strategy, and guidelines. Performs activities and generates reports for one or more significant subparts of the study (e.g., monitoring, data management, adverse events, deaths, protocol deviations, legal agreements, study training, patient informed consents).
* Develops or assists the study manager with the development of the required clinical documents (e.g., Clinical Management Plan, Clinical Investigational Plan), study budget, project schedule, study training materials, and study reports in consultation with the cross-functional team, investigators, and the core clinical team.
* Responsible for or assists with site identification, qualification, initiation, training, monitoring, and close out activities to ensure study compliance and subject protection.
* Responsible for site monitoring (review source documentation, case report forms, and data reports for accuracy and ensure the timely submission of such documentation) to assure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB, and Medtronic standards, guidelines and policies.
* Ensure accurate inventory accountability of investigative product at assigned sites.
* Assists with writing of abstracts, manuscripts, and sections of reports.
* May facilitate or assist with meetings with health care professionals for Investigator Meetings, Data Safety and Monitoring Boards/Clinical Events Committees, Advisory Boards / Steering Committees, and Publication Committees.
* May assist the Quality organization with project and investigator file audits.
* Provides coaching for entry level clinical study team members as capable and required.
* Will ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc) and implement contingency plans as needed
* Responsible for accurate and timely adverse event reporting during the study.
* Facilitates patient screening and enrollment at assigned clinical study sites to ensure adherence to FDA, Regulatory, IRB and Medtronic requirements.
* Work with investigators to quickly and effectively resolve problems.

Basic Qualifications

EDUCATION/TRAINING
*Bachelor’s degree
JOB EXPERIENCE
*BS or BA with at least 3 years experience supporting medical device clinical research within industry. MS, MA, or MPH with at least 2 years experience supporting medical device clinical research within industry or PhD, PharmD, DVM, or MD with at least 1 year experience supporting medical device clinical research within industry.
*Clinical data monitoring experience required
*Able to travel up to 40% and at the direction of the Manager.

Desired/Preferred Qualifications

EDUCATION/TRAINING
SKILLS/COMPETENCIES/KNOWLEDGE
*Proficient knowledge of medical terminology
*Significant knowledge of clinical and outcomes research study design, Good Clinical Practices, and global clinical regulations, including FDA regulations and ICH guidelines, for devices, biologics, and/or pharmaceuticals.
*Demonstrated ability to cultivate relationships with co-workers in a cross-functional environment
*Demonstrated ability to clearly and effectively communicate verbally and in writing
*High attention to detail and accuracy
*Advanced degree (e.g., MS, MA, MPH, PhD, PharmD, DVM, MD) in scientific field of study (e.g., biological science, social science, engineering, or other related medical/scientific field).
*Clinical research certification (ACRP, SoCRA)
JOB EXPERIENCE
*BS or BA with 4 years experience supporting medical device clinical research within industry.

Physical Job Requirements