Clinical Research Coordinator
Camris International

Overview

We are seeking a Clinical Research Coordinator to support the National Institutes of Health's National Institute of Allergy and Infectious Diseases' (NIAID) Vaccine Production Program 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

• Lead and manage the data quality and data management activities at the study level and support the overall operation and business needs for multiple internal and international Phase I-II clinical trials.
• Manage quality control of the clinical research data with compliance with regulatory requirements on all protocols to ensure compliance with institutional and organizational Standard Operating Procedures (SOPs).
• Lead and conduct the user acceptance testing of the clinical study database, review data and the study reports for accuracy, completeness, and consistency from the study start-up to database lock in compliance with the Manual of Operating Procedure (MOP) and SOPs.
• Lead, manage, and conduct the monitoring activities for three screening, sampling, and collection studies at the VRC.
• Extract and monitor clinical data to identify issues, provide feedback, and suggest solutions to the study team.
• Develop specifications for data listings, study reports, and data handling guidelines to check the validity of clinical research data.
• Support and train internal and external staff in using Clinical Research Data/Study Management systems.
• Assist in developing a Manual of Operating Procedures for multiple studies.
• Ensure adherence to the International Commission on Harmonization (ICH), Good Clinical Practice (GCP), and Code of Federal Regulations (CFR) standards.
• Facilitate and manage communications between end users and Clinical Data Managers through the iMeet ticketing system.
• Support the project conducted by the Data Coordinating Center (DCC) of creating, managing, and maintaining a secure repository for current and historical VRC clinical trial outcomes data and acquiring clinical and immunogenicity data.
• Support the FDA inspection process as needed.
• Support daily clinical data collection and reporting in Electronic Data Capture system (EDC) - Advantage EDC and eClinical, Clinical Trials Management System (CRIMSON), and Electronic Document Management System (Livelink).
• Provide support in the development of the CTP Quality Management System (QMS); actively contribute to the growth and development of this team by acting as QC and clinic operations liaison.
• Review data endpoints and track progress on matrix reports and monitoring reports to analyze research study status and evaluate performance.
• Review and edit original data collection forms (DCF) and provide quality control for translated DCFs.
• Assist in the development of preventive action to enhance study performance.
• Manage and review pertinent clinical study data to ensure compliant with FDA requirements through thorough quality control and quality assurance procedures.
• Develop standardized staff training templates and assist with the conversion of documents.
• Lead VRC Ops-Core Meetings monthly, including agenda preparation, facilitating communication, and documenting discussions and decisions.

Qualifications

• Master's degree in a related discipline. Two (2) years of specialized experience plus a BA/BS degree is equivalent to a Master's degree.
• Minimum of two (2) years of experience in clinical research or a related field is required.
• Demonstrates strong experience with data collection.
• Demonstrates experience with Microsoft Office (Word, Excel, etc.).
• Demonstrates advanced knowledge of research protocols and clinical, scientific and/or medical terminology.
• Candidates for the position must be willing to learn a variety of skills related to recruiting, counseling and providing details about our research studies.

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.

Full vaccination against COVID-19, defined as two doses of Moderna, two doses of Pfizer, or one dose of Johnson & Johnson's Janssen, is required for this position.

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.