Clinical Research Coordinator

Job opening ID

1427

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 a Clinical Research Coordinator to work onsite with the National Institutes of Health in Bethesda, 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:
•Coordinate with clinical staff to plan, prepare, implement, and monitor clinical research activities conducted by the laboratory, including subject accrual, monitoring of study data collection and entry into research databases, development and maintenance and review of case report forms, in accordance with data management and quality assurance plans.
•Provide expert guidance and assistance to clinical investigators in the writing, preparation and submission of protocols to the Investigational Review Board (IRB), including initial submission, continuing review, amendments, audits, and other administrative require-ments.
•Collaborate with PIs to manage, track and coordinate regulatory activities for the study protocols, during conception/development, as well as in all actions of protocol lifecycle, including scientific review, IRB initial and continuing reviews, IRB applications, bioeth-ics reviews, protocol amendments, study auditing activities, regulatory procedures involv-ing the FDA, applicable Data and Safety Monitoring Board (DSMB) reviews, and study closures.
•Maintain all clinical trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, participant source documentation and case report forms, trial logs and safety reports.
•Work with staff on the coordination and scheduling of monitoring and auditing visits by various regulatory bodies.
•Attend weekly staff meetings, as well as other meetings; work with protocol coordinators and other research and clinical staff on protocol navigation and quality control; guide the protocol navigation process. 
•Maintain and update inventory of laboratory equipment and research supplies and re-sources.

Required Skills:
•Master’s degree in a discipline related to biomedical research/clinical trials/health or a re-lated discipline; two (2) years of specialized experience plus a Bachelor’s degree is equiv-alent to a Master’s degree.
•Minimum of one (1) year of related experience.
•Experience with electronic data-management including proficiency in navigating clinical trials databases as well as other platforms including MS Excel, etc.
•Knowledge of regulatory requirements, FDA regulations (specifically IND regulations), Good Clinical Practices (GCPs), international guidelines, and other guidelines for clinical research, including the requirements of the institutional review board (IRB).
•Knowledge of medical and research ethics, including the ability to ensure participant con-fidentiality and privacy.
•Ability to perform project management functions, including delegation of tasks and en-suring deliverables are completed within a pre-specified timeframe.
•Strong communications skills, both oral and written.
•Excellent analytical, organizational and time management skills.
•Ability to multi-task and pay close attention to detail.
•Desirable but not required: 
oCertified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP).
oExperience related to clinical trial operations (e.g., development of Case Report Forms [CRFs]/electronic CRFs [eCRFs]), regulatory submission, patient schedul-ing and communications). 
oExperience interacting with the FDA, IRBs, and other regulatory bodies in order to make all required regulatory submission and address questions/stipulations.


Number of positions

1

Location

Bethesda

State

Maryland