Clinical Operations Coordinator
CAMRIS

Overview

We are seeking a Clinical Operations Coordinator to support the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a team focused on positively impacting millions of lives around the world. Candidates will work at a diverse and vibrant NIAID worksite to directly support ongoing research activities as a contractor team member. Take the next big step in your career and apply below to help us make a difference.

CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs.

Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

Responsibilities

• Independently work with pharmacists in the development and/or review of pharmacy specific documents (e.g. Pharmacy Establishment Plans) and standard operating procedures of relevance to Branch activities.
• Independently create and maintain a variety of electronic databases for all clinical research site pharmacy information and activities.
• Serve as an information resource on use of SharePoint applications and point of contact for resolving user problems.
• Independently create quarterly monitoring assignments based on pharmacy and protocol prioritization at clinical research sites for clinical site monitoring.
• 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 resolution.
• Create and track pharmacy special monitoring assignments.
• Manage a portfolio of sites in collaboration with a PAB Site pharmacist.
• Participate in site visits, as needed, to evaluate the facility, equipment, pharmacy personnel, and infrastructure capacity and provide report to PAB federal client.
• Create workflow and project management tools to track key milestones and/or identify potential problems associated with the review of Pharmacy Establishment Plans (PEPs) and complex protocols.
• Independently review and approve Pharmacy Establishment Plans. This includes interacting with outside stakeholders.
• Participate in Division meetings and assist the Branch with coverage for the HIV/AIDS Clinical Trials Networks' full group meetings and provide summaries as needed.
• Serve as a member of Branch and Office level working groups.
• Participate in protocol team or clinical research site conference calls with direction from PAB pharmacist.
• Work with PAB pharmacists in the development of protocol specific trainings for site pharmacists, which may include Power Point presentations and Manual of Operations.
• Develop, review and revise processes and procedures for Branch operations (e.g. SOPs, work instructions, guidance documents, etc.), in coordination with PAB federal client.
• Edit, rewrite, and/or proofread drafts of materials prepared by PAB pharmacists, as needed.

Qualifications

• Bachelor's degree in a related field.
• A minimum of 3 years of experience as a Certified Pharmacy Technician.
• Experience reviewing pharmacy specific documents and standard operating procedures (SOPs).
• Strong knowledge of Microsoft Office Suite (MS Word, OneNote, Excel, Outlook, PowerPoint, and SharePoint),
• Good communication and writing skills.
• Ability to effectively work independently and with others.

CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at www.CAMRIS.com . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.

Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.

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