Regional CRA - Texas
At SRG, we create meaningful connections that empower individuals and businesses to shape tomorrow’s world.
Working as part of the SRG team, you will work with our client which are Pharmaceutical or Bio-Pharmaceutical companies to ensure work quality and accuracy for our client in the Bio Pharmaceutical Industry. The Regional CRA is a remote role based anywhere within close proximity to major airport in South Central or West Coast (Texas, CO, AZ, CA). This is a long-term contract role (C2C, 1099 or W2) with a high potential to extend.
PURPOSE OF POSITION:
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.
- Bachelor’s Degree required – preferably within Life Sciences or other relevant technical area
- 5+ years of industry experience required
- 3+ years of monitoring experience for either CRO or sponsor is required
- Experience working within CNS is highly desirable.
- Candidates with experience in risk based monitoring will be considered first
- Knowledge of FDA, ICH, GCP, etc. regulatory requirements
- Professional certification through one or more relevant associations (e.g., ACRP, SOCRA, RAPS, etc.) desired
- Strong interpersonal skills and ability to work within a team in a fast-paced environment
- Experience working on multiple projects at one time
- Strong written and verbal communication skills
SRG 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.
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