Clinical Advisor

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 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 collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.  

• Provide human subject protections-related guidance on protocols and associated documents for DAIDS-supported human clinical research studies throughout the lifecycle of the protocol.
• Conduct scientific and full regulatory reviews of clinical research protocols and provide advice on human subject protections-related aspects of the protocol under review.
• Contribute to and participate in inspection preparedness activities.
• Possess and maintain knowledge of pertinent human subject protections regulations and guidance, including Office for Human Research Protections (OHRP), Food and Drug Administration (FDA) regulations, ICH guidelines, and any other applicable laws, regulations, policies, and guidance.
• Maintain up-to-date knowledge of NIH/NIAID/DAIDS policy and procedure changes related to human clinical trial participant safety.
• Communicate new information related to human subject protections, policies, and procedures to the departmental Branch Chief, OPCRO leadership, and other DAIDS staff and stakeholders.
• Participate in team calls, branch meetings and other meetings, as requested.
• Provide status updates and recommendations to the departmental Branch Chief, such as, on resolution of issues, etc.
• Develop briefings for the protocol team, departmental Branch Chief, OPCRO leadership and/or other DAIDS leadership, as requested. 
• Performs other duties as assigned.

• Minimum of a Master’s Degree and at least three (3) years of relevant experience years in the field of human subject protection and policy development.
• Experience with providing guidance on human subjects.
• Understanding and experience with ICH guidelines, FDA regulations, and any other applicable laws, regulations, policies, and guidelines.
• Experience in clinical research setting with protocols and clinical trials.
• Strong writing and recordkeeping skills.
• Strong collaboration and communication skills.

Physical Requirements:

The physical requirements described here are representative of those that must be met by a candidate to perform the essential functions of this job. Reasonable accommodations may be provided to enable individuals with disabilities to perform essential job functions.

• Constantly required to perform sedentary work that primarily involves sitting/standing.
• Rarely performs light work that includes moving objects up to 20 pounds.
• Rarely pushes or pulls less than 25 pounds and occasionally reaches above shoulder level.
• Constantly used both hands.
• Occasionally stands or walks for more than 25 minutes, and rarely bends, reaches or twists repeatedly.
• Constantly has clear vision (near and/or far), depth perception, peripheral vision and/or visual acuity.
• Constantly communicates with others to exchange information, and assesses the accuracy, neatness and thoroughness of the work assigned.
• Constantly works where no adverse environmental conditions are expected.

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.

CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.

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.