Overview

We are seeking a Project Manager to support the National Institutes of Health’s (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent, diverse and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member. Accelerate 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

• Provide support in quality control review & clinical operations outreach to ensure compliancy within protocol/research standards specific to clinical trial development, recruitment /outreach, research data collection, and general clinical operations with use of the CTP Quality Management System (QMS); actively contribute to the accurate retention of complex clinical data/records, by acting as Quality Control and Clinic Outreach Liaison maintaining institutional and organizational Standard Operating Procedures (SOPs) and Federal regulations as required.
• Assure adherence to International Commission on Harmonization (ICH), Good Clinical Practice (GCP), and Code of Federal Regulations (CFR).
• Ensure clinical notes adhere to protocol requirements, accurate input of clinical data and records information, aligning database cross-communications to secure data integrity. Verify that trial data is consistent with patient clinical notes and other source documentation (source data verification/review).
• Provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation.
• Audit research records, source documentation and practices to monitor compliance with applicable regulations. Identify areas of potential risk through audit processes, as well as assist with presentation of audit findings and design and monitoring of necessary corrective action.
• Identify training opportunities based on audits, design and present such education to prevent repeated compliance risks.
• Work closely with Safety office team and Research Nurses/Study Coordinators to oversee the data management process.
• Perform Quality Control (QC) checks on all trials as needed.
• Identify potential problems or inconsistencies in documentation and execute data cleaning with precision in accordance with GCP mandates.
• Assist in providing monitoring support for all facets of clinical trials and research.
• Perform internal QC monitoring visits to assure the research data with accuracy, accountability, documentation, and methods or procedures through review of CRFs, source documents, medical records, and regulatory documents.
• Assist in the overall recruitment and pre-screening effort of the team in accordance with each protocol utilizing VRC’s screening process criteria, in person or by telephone.
• Collect initial pre-screening health and demographic information by interviewing subjects to determine protocol eligibility.
• Enter information and communications in database to secure data integrity.
• Assist with and participate in community engagement (in a variety of settings including college campuses, community events, and community-based organizations) and study recruitment plans/strategies, to include marketing, community outreach, health education, etc. for all VRC clinical research studies in order to increase enrollment and name recognition.
• Assist in the development of recruitment materials such as data sheets, brochures, pre-screening documents, advertisement and other materials as appropriate for each engagement.
• Assist CTP team members with the day-to-day clinical administrative operations tasks, such as copying, filing and clinical data entry; maintain tools and supplies to ensure proper recruitment for research studies.
• Schedule participant screening visits in the VRC scheduling database.
• Respond and follow up to initial inquiries through email and calls.

Qualifications

• Bachelor’s degree in a related field.
• Minimum of two (2) years of experience in clinical research.
• Strong interpersonal and communications skills, both verbally and written.
• Strong organizational skills.
• Goal and detailed oriented.
• Ability to maintain a professional and positive attitude.
• Ability to work effectively in teams and independently.
• Proficient in MS Office Suite.
• Ability to simultaneously manage multiple projects.

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.