Clinical Trial Monitoring Specialist

One of our clients is seeking a talented and highly motivated Clinical Trial Monitoring Specialist. Please send your resume if you would like to pursue this opportunity and authorize Infosoft to represent you for this position.

Here are the job position details for your review:

Job Title: Clinical Trial Monitoring Specialist

Pay Rate: $50 to 56/Hr

Duration: 12 Months

Location: Remote with frequent travel to clinical sites (Pacific or Mountain Time Zone)

Our Client is a Global Medical Device Manufacturer.

We are looking for a Clinical Research Monitoring Specialist to perform remote and onsite monitoring activities, including verification of data collection for clinical trials, assessment of all data documentation, reports, records, and more.

Frequent travel is expected to clinical sites

• Develop and deliver training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, and regulatory documentation requirements
• Validate investigational device accountability by tracking the history of investigational devices from the Client to the field sites and through final disposition.
• Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
• Timely completion of monitoring visit reports and proactive action item tracking.
• Contribute to the development of clinical protocols, informed consent forms, and case report forms.
• Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, study sponsor management and leadership staff, and recommend and develop process improvements.

Must-Have :

• Medical devices monitoring experience
• High communication Good documentation practices
• Attention to detail, Understanding of FDA regulations
• Frequent travel is expected to clinical sites.

Education and Experience:

• Experience with Medidata RAVE and Medidata CTMS is preferred.
• Experience with cardiac trials and/or blinded trials is preferred.
• Experience with medical device monitoring is required.
• Bachelor's Degree or equivalent in a related field
• 3-5 years of experience required
• The candidate may or may not be an HCP (RN, NP, etc).