Regional CRA - NorthEast - new job in Remote, US

Regional CRA - Northeast

Regional CRA - 100% allocation needed for site monitoring in the Northeast for CNS clinical trials direct with a sponsor.

In this role you will be responsible for:

• Performing independent on-site or remote Monitoring procedures, i.e., Site Qualification, Initiation, Interim Monitoring, Site Close-out and site management.
• Overseeing study specific documentation such as Protocols, Monitoring Plans, CRFs, source documentation, CRF Completion Guidelines, Investigative Site training materials, maintenance of Trial Master File (TMF) format and studies, and QC of TMF.
• Managing and training clinical study sites.
• Providing Monitoring Visit Reports, Study Visits Communication Worksheets, Telephone Contacts and other reports as outlined in SOPs.
• Reviewing case report forms for legibility, correctness, and adherence to protocol requirements.
• Demonstrating a strong understanding of current GCP and ICH guidelines and regulations.

Qualifications:

• Bachelor’s Degree required – preferably within Life Sciences or other relevant technical area
• 5+ years of industry experience required
• 3+ years of CNS monitoring experience for either CRO or sponsor is required
• Professional certification through one or more relevant associations (e.g., ACRP, SOCRA, RAPS, etc.) desired
• Comfortable with air travel (required)

SRG ED&I and EEO Statement

• ED&I: Impellam Group and its brands are equal opportunity employers committed to diversity and inclusion.

• EEO Statement: Impellam Group is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.