What are the responsibilities and job description for the Clinical Research Protocol Navigator position at Columbus Technologies?
Must be a US Citizen or Green Card Holder
W2 with full benefit
Some travel may be required
Offer contingent on ability to successfully pass a background check and drug screen
Columbus Technologies and Services Inc. is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Columbus offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Clinical Research Protocol Navigator to work onsite with the National Institutes of Health in Bethesda, MD.
This is a long-term position which offers:
- Competitive salary
- Tremendous growth opportunity
- Opportunity to work at NIH, the world's foremost medical research center
- Learn more about what Columbus can do for you at www.columbususa.com
The US base salary range for this full-time position is $62/hr benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.
Responsibilities
Technical Requirements:
- Assists researchers with protocol development, assembly and review of clinical trial documents.
- Assists researchers develop and maintain trial related documents and operational procedures.
- Maintains study databases and conducts basic analysis.
- Assists researchers collect, distribute and file regulatory documents.
- Provides technical support to researchers and the clinic.
- Develops and assembles clinical trial documents.
- Develops and maintains trial related documents and operational procedures.
- Collects and distributes regulatory documents.
- Develops, assembles and reviews clinical trial documents.
- Collects, distributes and files regulatory documents.
- Reviews and recommends changes to clinical trial documents.
- Reviews and maintains trial related documents and operational procedures.
- Collects, distributes and submits regulatory documents.
- Develops training plans and trains staff on the proper techniques for protocol submission.
Qualifications
Specific Qualifications:
- Master’s degree in a science or health related discipline.
- Certifications: Association of Clinical Research Professionals Certified Professional (ACRP-CP), Association of Clinical Research Professionals (ACRP), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA)
- Experience with the following software: Clinical Trial Management System (CTMS), Electronic Medical Records System, Electronic Data Capture System
- Experience with the following: Liaising with regulatory authorities, Training clinical trial site staff, Previous clinical trial work, Phase I or II experience, Regulatory compliance, Protocol development, Protocol navigation, Regulatory affairs, Clinical Research, IRB submissions, Clinical Trials, On-site visits, Data Integrity, Research, ICH/GCP, Strong writing skills with experience writing clinical research protocols
Salary : $62
