Clinical Protocol Coordinator
CAMRIS

Overview

We are seeking a Clinical Protocol 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

• Manage clinical protocols by assisting in training the study team and other staff members, oversees compliance to protocol, develop and adhere to relevant SOPs; manage quality control, completion, and submission of study related documents; help in preparation, submission and maintenance of IRB, FDA, and/or other regulatory documents and research correspondence.
• Assist with development of informed consent and screening materials. Schedule and oversee study visits to NIH as needed.
• Interview, screen, recruit and enroll patients in IRB approved clinical trial protocols.
• Obtain informed consent/assent and addresses complex ethical and legal implications of same.
• 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.
• Use advanced communication skills to problem solve complex or unpredictable situations and to improve processes and services to patients and colleagues.
• Maintain study subject databases; oversee data collection and management including the collection of source documents, using, and developing CRFs, and ensuring that they are complete and accurate.
• Contribute to developing educational materials and educate the community and other research professionals regarding studies and related research issues. Assist with training staff members.
• Receive patient care phone calls, furnish the requested information, or refer callers to the appropriate staff members.
• Assist in medical documentation. Recruit volunteers for all protocols and collect and report census for all open protocols.
• Abstract medical information from medical history, medications, and preexisting conditions for new participants.
• Build and maintain excellent communication with Principal Investigators and others needed to conduct quality research to foster an excellent reputation of site research.
• Ensure efficient monitoring of all trials by ensuring that the data is clean and entered.

Qualifications

• Bachelor's degree in nursing.
• Licensed as a nurse in the state of Maryland.
• Minimum of 9 years of experience in clinical research setting with protocols and clinical trials is required.
• Knowledge of federal regulatory requirements pertaining to clinical research.
• Knowledge of Good Clinical Practice (GCP).
• Knowledge pertaining to privacy of the patient, privileged information and secure handling of the patient's medical records.
• NIH clinical trials experience preferred.
• This position and duties may be conducted remotely upon approval.

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.

This job has expired.