Clinical Research Coordinator
On-sitePortsmouth, Virginia, United States
Job Summary
Conduct IRB and IACUC approved research protocols, screen subjects using inclusion/exclusion criteria, and manage investigational drug accountability. Maintain detailed documentation of study charts, databases, and adverse events while coordinating with PIs for recruitment, enrollment, and randomization. Collect data, obtain laboratory results, and report unanticipated problems to governing agencies as required. Prepare correspondence for IRB, granting agencies, and sponsors, and assist in protocol closeout and funding sourcing. Maintain inventory of study supplies and ensure compliance with HIPAA and OSHA standards during specimen processing.
Required Qualifications
- US citizen
- Ability to obtain a Secret Clearance
- Bachelor's Degree from an accredited college or university
- Certified Clinical Trial Investigator (CCTI)
- Certified Clinical Research Coordinator (CCRC)
- Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA)
- A minimum of two (2) years as a Clinical Research Coordinator within the past five years OR Current certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA)
- Minimum of two (2) to four (4) years of monitoring experience in a clinical research environment and administrative Institutional Review Board (IRB) experience
- Possess knowledge of medical terminology and clinical monitoring process and in depth therapeutic and protocol knowledge
- Ability to communicate effectively, both orally and in writing
- Possess effective organizational and analytical skills with ability to work independently and in a team environment
- Proficiency with Windows base computer systems, including Microsoft Windows and Microsoft Office Suites program
- Must possess the ability to complete research subject protection training developed by the Collaborative Institutional Training Initiative (CITTI), and additional protocol specific training, as required, within one month from start date
- On-site (local candidates only)
Desired Qualifications
- Clearance: (ability to obtain) Secret Clearance
Additional Requirements
- Must be a US citizen
- Ability to obtain a Secret Clearance
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