Clinical Research Specialist

Redbock - an NES Fircroft company; Minneapolis (MN); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading clinical research firm is seeking a Clinical Research Specialist for a 24-month contract available on-site in Minneapolis, MN or Lafayette, CO. The role requires managing clinical evaluation studies, overseeing site operations, and ensuring compliance with Good Clinical Practices. Ideal candidates will possess a Bachelor's or higher degree, with a minimum of 2 years of relevant experience, specifically in site management and knowledge of clinical systems. This position offers a comprehensive approach to clinical trial management.

Qualifications

• Minimum 2 years of site management experience with a Bachelor's degree.
• 1+ years of experience required if holding an advanced degree.
• Strong knowledge of clinical practices and management systems.

Responsibilities

• Oversee and manage clinical evaluation research studies.
• Prepare protocols and patient record forms.
• Conduct clinical studies ensuring they meet medical needs.
• Interpret clinical investigation results for drug applications.
• Manage operational aspects of clinical trials aligning with regulations.
• Handle clinical supply operations and site/vendor selection.

Skills

Site Management experience

Knowledge of CTMS/EDC/TMF

Experience with Good Clinical Practice (GCP)

Experience with CTMS and patient data management systems

Experience with Microsoft Office Applications

Education

Bachelor's degree

Advanced degree

Tools

Veeva Vault

RAD Rave

Oracle

Job description

Clinical Research Specialist (24 month contract // Available on-site in Minneapolis, MN or Lafayette, CO)

HM's Top 3:

• Site Management experience (site and/or sponsor)
• Knowledge of/experience with CTMS/EDC/TMF
• Experience with Good Clinical Practice (GCP)

Years’ Experience Required: Minimum 2 years with Bachelor’s degree and 1+ years experience with advanced degree

Description:

Individual will be responsible for site management duties. Individual will serve as main contact for sites assigned to their care and ensuring sites are prepared for study participants, answer site questions, and ensure site milestones are met.

Duties:

• Oversees, designs, plans and develops clinical evaluation research studies.
• Prepares and authors protocols and patient record forms.
• Conducts registered and nonregistered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
• Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.
• Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets.
• May be responsible for clinical supply operations, site, and vendor selection.

Must Haves:

• Experience with CTMS and patient data and site management systems (i.e. Veeva Vault, RAD Rave, Oracle)
• Experience with Microsoft Office Applications