Clinical Research Coordinator

5 days ago

Rockville, United States Contemporaries Full time
Job DescriptionJob Description

Contemporaries Inc. is a government contracting firm providing support to the National Institutes of Health to assist with hiring an experienced Clinical Research Coordinator/Study Coordinator to work on a 5 year contract. The purpose of this position will be to support the planning and executions of research studies and trials working with individuals with disabilities or minorities. This is a hybrid position with in-office days working in Rockville, MD. Selected candidates will be required to have a Master's degree in a discipline related to public health, biomedical research, or a related subject. Candidates should have at least 4 years of related experience in a health research setting. 

Duties: 

  • Coordinate and administer on average 3 to 5 research studies. 
  • Provide regulatory support for research studies and randomized trials including but not limited to reviewing and ensuring that protocols and informed consent documents meet regulatory requirements and are written in a format compatible with the guidelines and suitable for use among racially, ethnically, and linguistically diverse populations. 
  • Develop and adhere to study protocols and standard operating procedures. 
  • Connect with participants/patients to schedule participant/patient visits and follow-up according to protocol requirements. 
  • Manage day-to-day activities related to inquires from participants/patients enrolled in studies or those interested in joining planned studies. 
  • Work with PIs and associated research staff on the coordination and scheduling of monitoring and auditing visits by various regulatory bodies as needed. 
  • Attend in-person meetings pertaining to protocol development, research coordinator forum meetings, as well as regular research team meetings. 
  • Attend training activities to maintain a current clinical trial and GCP knowledge base to serve as an expert resource to PIs in a regularly changing field and adhere to GCPs. 
  • Collaborate with NIH research scientists, PIs, Research Coordinators, Protocol Navigators, etc. 
  • Coordinate with other offices to integrate and ensure consistency of new/revised documents with policies. 
  • Work with PIs on protocol writing and editing.
  • Manage, track, and coordinate research and regulatory activities for all assigned protocols, under the guidance of the PI. 
  • Maintain necessary documentation and reports for ongoing and projected research studies.
  • Draft cover letters for journal submission, submit manuscripts to journals, co-author and edit manuscripts. 

Profile: 

  • Must have a Master's degree related to public health, biomedical research, or a related discipline. 
  • At least 4 years of related experience with 2 years of experience coordinating research studies. 
  • Experience with primary data collection among diverse populations including participants with low-literacy. Experience developing surveys, focus groups guides, and respondent tracking systems. 
  • Knowledge of regulatory requirements, NIH regulations, GCP, and other guidelines for social behavioral health research. 
  • Experience interacting with Institutional Review Boards and other regulatory bodies to make required regulatory submissions and address questions/stipulations. 
  • Strong communication skills. 
  • Seeking candidates with a CCRC or CCRP.
  • Experience working with a Contract Research Organization is preferred.
  • Experience related to randomized trial operations (development of case report forms, regulatory submission, patient scheduling, and communications). 

 

Company DescriptionContemporaries is a government contracting firm who has been providing HR and Staff support to both federal and private organizations for over 32 years. Specializing in Administrative and related opportunities, while also working with Scientific, IT, Legal, Research, and related opportunities.Company DescriptionContemporaries is a government contracting firm who has been providing HR and Staff support to both federal and private organizations for over 32 years. Specializing in Administrative and related opportunities, while also working with Scientific, IT, Legal, Research, and related opportunities.

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