Senior Clinical Research Associate

NCGS, Inc - Washington, DC2.3

Full-timeEstimated: $64,000 - $80,000 a year
NCGS seeks home-based Senior Clinical Research Associates for independent onsite clinical monitoring nationwide for phase 1-1V in the following therapeutic areas- CNS, oncology, infectious disease, critical care, and women’s health.

Sr. CRAs independently conduct onsite monitoring responsibilities for clinical trials, according to NCGS Standard Operating Procedures, FDA/ICH guidelines and GCP, including Pre-study, Site Initiation, Routine Monitoring and Close-out Visits.

Primary Responsibilities

Participate in the review of clinical protocols, case report forms or edit specifications and recommend clinical or operational changes
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Demonstrated ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures
Reviews or authors informed consent forms, monitoring plans, training materials, site study manuals, and related study documentation
Coordinate efforts in study start up through closeout activities, including: study feasibility, site selection, preparation and follow-up of site regulatory packages
Coordinate and conduct CRA and site training of protocol and operational requirements
Ensure consistency in instructions to investigators and their personnel for compliance with protocol and regulatory requirements
Manage key study parameters (study start-up activities, drug inventory, lab supplies, non-clinical study supplies, screening activity, subject recruitment plans and efforts, lab sample management, safety reporting procedures, metric assessment, data collection, blinding plan, vendor interface, etc.) and in collaboration with the project manager or Lead CRA and proactively identify solutions within the study team when issues arise and measure intervention success if required
Create and implement project tools, tracking tools, etc. to report study specific metrics
Prepare progress updates
Manage all study supply requirements (storage, distribution, site inventory, etc.)
Assist with the projection and management of clinical supply inventory.
Performs independent monitoring of sites as required by needs of project
Conduct co-monitoring visits
Conduct audits of other monitors, clinical sites, supplier inventory, etc.
Assist in the review of clinical study reports for accuracy
Review, write and/or edit SAE narratives
Use well-developed problem-solving skills to address needs of program or skill development of team members
Perform other duties as assigned by management.

Our ideal team member will have:
A medical science related degree from an appropriately accredited institution
Minimum of 4-6 years of independent onsite clinical monitoring experience with 2 years in a home-based environment
Good oral and written communication skills, with the ability to communicate effectively with medical personnel
Proven flexibility and adaptability
Ability to work collaboratively in a team or independently as required
Skilled with Microsoft Office with the ability to learn appropriate software and internet based programs
Experience on multiple research studies in diverse therapeutic areas
Ability to travel 60-80%
Authorization to work in the US for any employer