Clinical Advisor - CAMRIS

Overview

We are seeking a Clinical Advisor 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

• Oversee all aspects of participant study outpatient visits and inpatient admissions.
• Communicate with potential participants and screen for eligibility for study.
• Obtain and review potential participant medical records and history to determine eligibility.
• Schedule participant visits and coordinate travel and housing for participants.
• Coordinate participant schedule, consultations, and imaging appointments.
• Ensure safe handling of various specimens in accordance with prescribed protocols.
• Review patient care policies and procedures utilizing NIH guidelines as it relates to patient admissions.
• Maintain appropriate research records in CRIS.
• Consent and maintain research documents for participants.
• Coordinate recruitment, consent, and specimens for mail-in biologic specimens.
• Communicate and assist the Federal Task Leader and multidisciplinary research team to ensure that patient management strategies are successful in meeting patient care and research needs.
• Communicate with participants, their caregivers, and physicians regarding appointments, laboratory findings, and imaging results, and management plan as needed.
• Receive patient care phone calls, furnish the requested information, or refer callers to the appropriate staff members.
• Contribute to the design, methodology, implementation, and regulatory review of specific protocols as assigned.
• Coordinate multi-site IRB protocol in which NIH is the IRB of record including maintaining participant logs in coordination with other sites.
• Coordinate single-site IRB protocols at NIH.
• Ensure that all procedures are being carried out per protocol.
• Collect and ensure that sample volumes collected are within protocol limits.
• Assist and ensure the safety of human subjects while procedures are being performed.
• Create participant logs and monthly and annual reports for open studies.
• Assist IRB review cycle submissions, including initial review, continuing review, amendments, and reports in accordance with IRB, NIH and other applicable regulations.
• Assist with the design, methodology, implementation, and regulatory review of research protocols, including informed consents, manual of operating procedures, and SOP’s.
• Practice and follow Good Clinical Practices and federal human subjects research regulatory requirements and ensure compliance of research protocols with relevant requirements.
• Coordinate with the IRB, Office of Human Research Protection, and other regulatory authorities at NIH and other sites as needed.
• Respond to inquiries and audits from regulatory agencies, including researching the issues, assembling documentation, and preparing written responses.
• Organize research information for clinical projects.
• Create and review sample submission forms for accuracy prior to database entry.
• Create and maintain database of clinical information for use in clinical research studies.
• Create data collection forms for research studies and collect relevant data.
• Provide a detail-oriented approach, able to work independently and efficiently to track multiple deadlines and keep projects on target and moving forward.
• Anticipate and identify problems, consider alternatives, and work collaboratively and creatively to solve problems.

Qualifications

• Bachelor’s degree or higher is required.
• Minimum of two (2) years of related work experience is required.
• Professional verbal and written communication.
• Ability and willingness to work on a team.
• Must be able to be credentialed by the NIH Clinical Center.
• Knowledge pertaining to privacy of the patient, privileged information, and secure handling of the patient’s medical records.
• Must complete all security and training for use of NIH databases and software and must follow and adhere to PII regulations.
• Experience using Microsoft Office products including Outlook, SharePoint, MS Teams.

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.