Clinical Research Coordinator
Camris International

Overview

We are seeking a Clinical Protocol Coordinator to support the National Institutes of Health's National Institute of Allergy and Infectious Diseases' (NIAID) Laboratory of Allergic Diseases (LAD) 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

• Provide advanced expertise in clinical trial coordination and implementation, data and protocol management. Oversee the implementation, tracking, data abstraction and collection, data reporting, and coordination of a variety of clinical trials in affiliation with the NIAID/DIR program.
• Interview, screen and recruit patients for entry onto protocols.
• Ensure that families of participants are properly consented and understand implications of genetic research. Screen patients, obtain medical history, and acquire outside medical records and pathology specimens, while addressing complex ethical and legal implications.
• Perform, and/or coordinate the collection, processing and handling of laboratory samples including appropriate storage and shipping.
• Coordinate the procurement of samples from referring physicians worldwide to further the laboratory's research.
• Monitor response to therapy and adjusts plan of care per protocol specifications, standards of practice, and other guidelines.
• Use sound judgment and clinical expertise to adjust patients' plans of care in the absence of established guidelines.
• Document informed consents in CRIS and CRIMSON patient medical information systems.
• Manage protocols relating to human subjects research and the collection and processing of human samples procured under the auspices of NIH IRB-approved clinical research protocols.
• Work to maintain NIH IRB protocol and office files, databases, and records. Provide administrative and technical guidance to investigators and institute staff on NIH IRB functions.
• Assist investigators and staff and ensure that all NIH IRB policies and procedures are disseminated to the Federal Task Leader and other appropriate program staff via written and electronic communication.
• Assist the clinic staff with regard to Investigator Brochure information, protocol implementation, general and specific data collection and research practices.
• Direct health care members in the execution of trials and resolution of logistical constraints and assures all aspects of Good Clinical Practice (GCP) and federal regulatory requirements are met or exceeded.
• Assist and explain to families on basic concepts of the human immune system and hereditary disease as it relates to their illness.
• Establish rapport and works with families under stress, provide emotional support and refers to appropriate resources.
• Process and guide research protocols through the review cycle of submission, initial review, continuing review, amendments, and reporting. Obtain translations of protocol consents into various languages and updates translated consents as needed. Arrange for translators in advance of protocol visits.
• Assist in preparing and analyzing clinical data for publication in biomedical journals.
• Serve as a primary contact point for the Laboratory for protocol procedures and regulations.
• Provide administrative and technical guidance for new investigators.
• Conduct educational presentations to nursing units, clinics and other departments collaborating on NIAID clinical trials.
• Ensure compliance with training for protection of human subjects, conflict of interest guidelines, and patient confidentiality. Ensure accurate and timely entry of data to bio-specimen databases.
• Maintain integrity of databases by conducting periodic audits and reports to Laboratory chief.
• Provide advice and expertise to technicians on maintaining Clinical Laboratory Improvement Amendment (CLIA) certification for the Laboratory where appropriate and participates in CLIA inspections.
• Serve as a primary contact point for the Laboratory in regard to protocol procedures, regulations and requirements. Serves as the liaison between various individuals and offices involved in the oversight of human subjects research at the NIH including, but not limited to, the NIH IRB, the NIAID Clinical Director, the Office of Human Subjects Research, the NIH Office of Clinical Research, NIH Clinical Center Office of Protocol Services, Deputy Ethics Coordinators, NIAID's Technology Transfer and Intellectual Property Office (TTIPO), and investigators.
• Serve as the liaison between Laboratory and other teams in NIAID, clinical nursing staff, NIH Clinical Center Staff, other institutes and centers of the NIH, extramural collaborators, referring physicians, patients and their families.
• Participate in the development and maintenance of hard copy and electronic systems to prepare, monitor and track protocols and submissions. Participate in the development and maintenance of systems used to manage databases and to monitor compliance with applicable regulations. Maintain files and records on all protocols for the required periods of time.
• Creatively solve problems related to obtaining viable patient samples from international locations and from patients with limited resources.
• Collaborate with many of the following professionals and/or organizations: pharmacy, laboratories, pharmaceutical agencies/sponsors and monitors, Contract Research Organizations, the Food and Drug Administration, and the Institutional Review boards and IND holders.
• Direct and perform quality assurance and quality control activities as they relate to protocol adherence, protocol monitoring, data collection, data abstraction, and data analysis and assures standard operating procedures reflect the highest standards of data integrity and patient safety.
• Report data to appropriate regulatory and monitoring agencies. Anticipate and create database/case reports to meet protocol needs. Translate data collection needs into clinic wide standards and tools, collaborating with resources beyond the intramural setting to maintain data collection tools.
• Perform activities to facilitate the ease of reporting, avoidance of repetition of data entry procedures, and generation of reports appropriate to various agencies.
• Stay current with NIH IRB requirements. Prepare reports and respond to outside inquiries and audits from IRB oversight and regulatory offices including, but not limited to, the NIH Intramural Research Program's Human Research Protections Program, the NIH Office of Human Subjects Research Protections, and the HHS Office of Human Research Protections.
• Design and maintain a selection of material appropriate to send to health care referral sources seeking eligibility information or for other appropriate objectives.
• Analyze data, note trends and implications of same, publishes and presents finding locally, nationally and internationally representing NIAID and DIR.
• Use advanced communication skills to problem solve complex or unpredictable situations and to improve processes and services to patients and colleagues.
• Write expert documents relevant to research, clinical care and related subjects including published works and executive reports.
• Act as a mentor to students and nurse specialists/practitioners new to the NIAID/ NIH Clinical Center environment. Provide information and educating to others in the field of expertise including lecturing at colleges and continuing education programs.
• Participate in clinical practice and research support peer review and develops multidisciplinary performance improvement programs and projects. Maintain an overview of the clinical program in order to collaborate and contributes to planning and resource allocation.
• Collaborate with peers and other multidisciplinary team members to analyze and evaluate current systems of health care delivery and to identify and implement new practice patterns as appropriate.

Qualifications

• BSN or MSN degree, and a valid Nursing license is required.
• Minimum two (2) years of related work experience is required.
• Experience in pediatric nursing is required.
• Effective communication skills working in a collaborative team atmosphere.
• Ability to maintain strict compliance with IRB, NIH and Federal Regulations governing human subjects research.

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.