Clinical Research Monitor- CRA (Northridge, CA) Job at Medtronic
Careers That Change Lives
In this exciting role as a Clinical Research Monitor you will have responsibility for monitoring Clinical Research data, working with site personnel and internal study team members, and functional partners to ensure subject protection and integrity of clinical research data.
Diabetes:
The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We’re committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day.
This is a full time onsite position based out of our Northridge, CA office.
A Day in the Life
- Monitors progress of clinical studies at the Medtronic Clinical Site
- Ensures clinical research studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements.
- Develops and maintains liaison with clinical investigators, affiliated hospitals, and research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical devices approval.
- Partners with Medtronic functional representatives to ensure adherence to SOPs and other internal practices
- Responsible for reviewing adverse event and device deficiencies with investigators.
- Review source documentation and case report forms for accuracy, completeness, and timely submission
- Conducts site qualification, initiation, monitoring and close-out visits
- Monitoring Action Item and query resolution
- Monitoring Visit Reports submission and completion
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
- Bachelor’s degree with a minimum of 2 years of clinical research/clinical monitoring experience
OR
- Advanced degree with a minimum of 0 years of clinical research/clinical monitoring experience
Nice to Have
- 2+ years of Clinical Research experience in medical device industry
- Degree in engineering, life sciences, or related medical/scientific field.
- Proficient knowledge in medical terminology
- Proficient knowledge in MS Office Productivity Tools
- Knowledge of ICH-GCP guidelines
- Knowledge of IRB and FDA compliance
- Knowledge of 21CFR 812
- Source Data Verification
- CCRA certification (Certified Clinical Research Association), ACRP, CCRP, SOCRA, or equivalent preferred.
- Experience with Good Clinical Practice (GCP), ISO14155 and/or regulatory compliance guidelines for clinical trials/data collection.
- Ability to appropriately apply different standards related to medical devices/ clinical research (SOPs, GCP, ISO, ICH, FDA, MedDev, etc.), as needed.
- Experience with audits/compliance within clinical/quality/regulatory and regulatory inspections (e.g., FDA – BIMO, Notified Body (Europe))
- Ability to incorporate and adhere to applied standard practices and regulatory standards.
- Clinical Research experience at Medtronic or within the medical device industry or pharmaceutical industry.
- Experience in sponsor-initiated clinical trial experience managing clinical site personnel
- Experience working with the clinical study lifecycle (e.g., planning, execution, and closeout)
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers.
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here .
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here
The provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
Please Note :
www.epokagency.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, www.epokagency.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.