Clinical Advisor

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

• Ensure the most current domestic and international regulatory safety reporting requirements are used (e.g., ICH guidelines, FDA, EU and other national and international requirements).
• Provide expert scientific and safety-related expertise to medical officers, study teams, and site investigators to include reviewing and providing comments to DAIDS medical officers on protocols and working with DAIDS medical officers to develop risk management/safety monitoring plans, as needed, for DAIDS-supported studies.
• Serve as a subject matter expert on the safety reporting needed for new Clinical Trial Agreements, safety data exchange agreements, clinical materials transfer agreements and Communication plans.
• Provide Expedited Adverse Event (EAE) reporting and safety management expertise and related safety support functions to include serving as a point of contact with project officers, contractors, grantees and intramural staff participating in both domestic and international studies and supporting the DAIDS Adverse Experience Reporting System (DAERS).
• Provide MedDRA coding expertise and support MedDRA-related activities.
• Develop and/or review a variety of safety-related documents and training materials for use by DAIDS, its CROs and partners (e.g., policies, procedures, work instructions, guidance, and training materials related to safety monitoring and reporting requirements for DAIDS-sponsored clinical trials).
• Provide advice in matters related to safety and pharmacovigilance which includes developing pharmacovigilance practices such as set-up and configuration of the safety database, signal detection, trend analysis, analysis of aggregate safety and adverse event data to identify safety concerns in Division-supported clinical trials and provide expertise in preparing reports related to the manufacturing of investigational products such as development safety update reports (DSUR).

Qualifications

• MD or Master’s degree in a health related field.
• Minimum of ten (10) years of related experience.
• Experience in safety reporting requirements; domestic and international.
• Understanding and experience with ICH guidelines, FDA regulations, EU and other national and international regulations.
• Experience in clinical research setting with protocols and clinical trials.
• Strong writing and record keeping skills.
• Strong collaboration and communication skills.

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.