Clinical Research Coordinator

Job opening ID

1845

Posting title

Clinical Research Coordinator

Roles and responsibilities

Must be a US Citizen
Some travel may be required

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 Clinical Research Coordinator to work onsite with the National Institutes of Health in Rockville, MD.

This is a long-term contract 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

Job Description:
•Work with pharmacists in the development of a variety of documents (e.g. Pharmacy Establishment Plans) and standard operating procedures of relevance to Branch activities. 
•Maintain a variety of electronic databases and SharePoint sites relevant to pharmacy activities.
•Develop and maintain clinical research site pharmacy information resources (site folders and documents) and verify that all required documents and sections of the Pharmacy Establishment Plan are included.
•Review and process notifications of change in the Pharmacist of Record (PoR), Associate Pharmacist, and Change in contact information and address forms. 
•Create quarterly monitoring assignments based on pharmacy and protocol prioritization at clinical research sites for clinical site monitoring
•Participate in site visits, to evaluate the facility, equipment, pharmacy personnel, and infrastructure capacity and provide report to leadership.
•Create work flow and project management tools to track key milestones and/or identify potential problems associated with the review of Pharmacy Establishment Plans and collaborate with pharmacists to resolve those issues
•Review site pharmacy monitoring reports and use the NIAID web-based clinical site monitoring system to address any issues noted with the site pharmacist until they are re-solved.
•Participate in Division meetings and assist the Branch with coverage for the HIV/AIDS Clinical Trials Networks’ full group meetings and provide notes.
•Assist the Branch pharmacists in the development of protocol specific trainings for site pharmacists.
•Participate in protocol team conference calls when the PAB Protocol pharmacists are not available.  This includes conveying information from the PAB pharmacist to the team, answering questions if able, and bringing back issues to the PAB pharmacist for resolution.
•Serve as primary liaison for study product destruction activities.  
•Develop the weekly iPOD chart, a reference for staff regarding the pharmacist responsible for responding to site inquiries.
•Maintain branch meeting agendas and prepare minutes.

Required Skills:
•Bachelor’s degree in a related discipline; eight (8) years of specialized experience plus a high school diploma is equivalent to a Bachelor’s degree.
•Minimum of four (4) years of experience in clinical research or a related field. Demonstrates strong experience with data collection. Demonstrated experience with Microsoft Office (Word, Excel, etc.).
•Certified Pharmacy Technician.
•Hospital pharmacy experience; however, retail pharmacy experience considered.
•Knowledge of Good Pharmacy Practice and Good Clinical Practice.
•Ability to work independently and as part of a team.
•Strong organizations skills.
•Excellent oral and written communication skills.

Number of positions

1

Location

Rockville

State

Maryland