Social & Scientific Systems (S-3)

Clinical Research Coordinator III

US-MD-Silver Spring
Job ID
2017-1679
Category
Clinical
Type
Regular Full-Time

Overview

Social & Scientific Systems (SSS) works to improve public health worldwide by providing technical, research, and program management services to government, nonprofit, and commercial clients. The SSS team offers a synergy of expertise in clinical research services, epidemiology and public health studies, health data management and analysis, and program evaluation and policy analysis. Please join our dedicated staff of employee-owners in an environment that values diversity and supports health, well-being, and professional growth.

 

 

Responsibilities

  • Participate in reviewing protocols, amendments, investigator brochures, Informed Consent Forms (ICFs) and CRFs and facilitate Institutional Review Board (IRB) submission, queries, and approval.
  • Demonstrate documented advanced training in GCPs as well as significant experience in clinical trial monitoring, including paper and Electronic Data Capture (EDC) studies.
  • Participate in the development and preparation of study master protocol and site-specific protocols, study-specific training materials, study reference binders, subject diaries, informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND applications, IND Annual Updates, New Drug Applications (NDAs), budget and proposals, protocols, informed consent, case report forms, statistical analysis plans, clinical study reports, data management plans and other documents as required.
  • Monitor project tasks, timelines, and deliverables from project planning and initiation to close out for all on-going and planned clinical trials. The contractor shall notify the team of potential clinical trial risks and propose appropriate corrective course of action for risk mitigation.
  • Coordinate with multidisciplinary project team members related to project management activities requiring interaction with other groups such as regulatory affairs, clinical monitor, support contractors, vendors, data management, biostatistics, product compliance and quality, pharmacovigilance, collaborators, sponsors and shipping/logistics.
  • Provide written and verbal reports on status of clinical trials and significant issues impacting clinical trials at a frequency requested by the Government team lead.
  • Develop tools for management, monitoring, and reporting on status of clinical trials.
  • Coordinate site reports and provide clinical trial status updates to the Government team lead for all sites as necessary.
  • Assist in monitoring regulatory review progress for all clinical sites, including but not limited to Scientific Review, IRB, and second level Department of Defense review, particularly tracking submission/approvals and continuing review reports.

Qualifications

  • Bachelors degree in Science/Health-related fields (Nursing, Medical Terminology, Biology, Biochemistry); Masters degree is preferred.
  • 5 or more years of experience in clinical trial monitoring or appropriate experience transferred from related occupation such as RA Specialist, Quality Assurance, Site Coordinator related to clinical trial research.
  • Certifications – Certified Clinical Research Profession (CCRP) or Certified Research Associate (CCRA) is preferred
  • Must possess documented advanced training in GCP’s as well as significant experience in clinical trial monitoring, including paper and Electronic Data Capture (EDC) studies. Knowledge, Skills and Abilities:
  • Must have excellent verbal and written communication skills; excellent interpersonal and client management skills
  • Strong working knowledge of GCPs, ICH guidelines, FDA and/or EU guidelines
  • Experience monitoring multiple Phase I-IV clinical studies
  • Proficiency in all MS-Office applications including Microsoft Word, Excel and PowerPoint, MS Projects a plus.
  • Must possess a professional and customer service oriented demeanor
  • Experience working in matrix environments; ability to work well in a team environment
  • Ability to perform job specific responsibilities with minimal supervision




SSS is committed to fostering a diverse workforce and is proud to be an Affirmative Action/Equal Opportunity Employer of Minorities/Women/Protected Veterans/Individuals with Disabilities. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, sex, age, national origin, veteran status, disability, or any other classification protected by law.

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