Sr Clin Research Monitor (CRA)
18000 Devonshire Street Sherwood Forest, CA 91325 US
In this exciting role as a Sr. 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.
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.
A Day in the Life
- Monitors progress of clinical studies at the 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 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 4 years of clinical research/clinical monitoring experience
- Advanced degree with a minimum of 2 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 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)
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.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.