Current jobs related to Clinical Advisor - Bethesda - CAMRIS

Overview:
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.
- Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required._