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 activ... more details
Clinical Advisor
Job LocationsUS-MD-Bethesda
# of Openings
1
Category
NIAID
Type
Regular Full-Time
Min
USD $80,000.00/Yr.
Max
USD $109,000.00/Yr.
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
Lead the creation, implementation and appropriate closeout of an overall operational plan for one or more treatment studies including COVID-19 trials. Activities may include but not limited to timeline, key milestones, resources needed and budget.
Assess the operational feasibility and resource considerations of new entrants to said trials.
Work through established contract resource organizations and with the sponsor, networks and company partners:
Create a global site/country strategy.
Oversee the execution of that strategy including site selection including feasibility, qualification and pre-study assessment.
Oversee site activation including, the provision of investigational product, non-IP clinical supplies and laboratory materials; the completion of required regulatory documentation and the granting of needed systems access.
Coordinate efforts to recruit participants into the trial including global trial and site specific recruitment plans, media and outreach programs and vendor programs.
Oversee the execution of the study monitoring and oversight plan. Ensure site productivity and quality issues are actively managed.
Oversee the executions of the data management plan. Ensure that queries are resolved and database closure occurs on time.
Oversee the study close-out plan.
As needed, review processes (or lead a team that reviews the processes) that relate to or impact any of the above items and work with implementing partners to revise SOPs, process pathways, and implementation plans to effect more efficient or rapid outcomes.
Create and oversee the execution of a study risk management plan. Proactively resolve risks to operational delivery.
Support meeting documentation and follow-up action items.
Facilitate reporting of study status to key stakeholders in the US Government including NIH, the ACTG, and other partners/collaborators.
Qualifications
B.S./B.A.degree in a related field.
Minimum of ten (10) years of related experience.
Experience in overseeing the creation and implementation of treatment studies.
Excellent communication and interpersonal skills, with the ability to effectively collaborate across diverse teams and influence stakeholders at all levels of the organization.
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.
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