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The Clinical Team Lead is integral to driving project success. This position will independently manage and monitor clinical trial sites, and will function as the Lead CRA on select projects. In the Lead role, this position will be responsible for providing direction to and training for other CRAs assigned to those projects. In addition, the clinical team lead is responsible for the oversight of all operational aspects related to the planning and management of site performance.
The Clinical Team Lead will be responsible for ensuring that sites and CRAs operate in compliance with study protocols, ICH/GCP guidelines, and Federal Regulations.
This is an office based opportunity. Candidates must be willing to relocate to the Raleigh/Durham/Chapel Hill area and reside within a 1 hour commute distance of the office.
Required to travel 25% on average.
Rho is searching for a Regulatory Scientist who will provide technical and strategic regulatory services necessary to perform government-funded vaccine and infectious disease research. The Regulatory Scientist will provide technical and regulatory guidance and support to cross-functional teams and projects of varying scope for the development of clinical study design, product development plans and regulatory submission strategies, filing necessary applications and handling government interactions pertaining to the regulation process for products requiring regulatory authority approval.
The Regulatory Scientist position will be located in Silver Spring, Maryland and requires the applicant to be onsite at the client’s location on a daily basis. This position will be filled contingent upon contract award. Work will begin in late July or early August 2019.
The Senior Administrative Assistant I will provide a wide range of complex, confidential administrative tasks in support of the Corporate Services team, while also overseeing and directing the work of others. This individual must deliver excellent customer service to both internal and external clients, be a team-oriented professional with strong initiative, be highly organized and able to prioritize team and individual tasks, demonstrate exceptional attention to detail, and have strong written and oral communication skills. This individual must have the ability to maintain confidentiality and exhibit excellent judgment and sensitivity.
The Senior QA Auditor will provide technical expertise to Rho’s Quality Assurance function. This individual will act as an independently functioning QA professional in providing quality assurance-related solutions to both internal and external customers. The Senior QA Auditor will also be responsible for building and maintaining effective working relationships throughout Rho and for mentoring and cross-training with QA teammates.
A Statistical Research Associate supports the Rho Biostatistics, Statistical Programming, and Data Management team members with documentation, organization, administration, and communication tasks. A Statistical Research Associate may also work on special, non-recurring and ongoing projects.
The Director of Regulatory Operations oversees the technical preparation, submission, and archiving of all regulatory submissions prepared by Rho on behalf of Rho’s clients, and ensures that all submissions to regulatory authorities are produced on time per project timelines and comply with regulatory authority requirements. The Director plays a critical leadership role with oversight of Rho’s publishing and operations personnel, capabilities, systems, and processes, to effectively publish and submit timely, high-quality, compliant regulatory submissions.
The Sr. Statistical Programmer will convert data from specifications and statements of problems to computer code. The person in this role will consult with sponsors, project leads, systems analysts, other programmers, and end users to gather information about program intent, functions, features, data requirements, input requirements, output requirements, internal and external checks and controls, hardware and operating system environment, and interfaces with other systems. A particular focus of this position will be Study Data Tabulation Model (SDTM) specifications.
The Clinical Research Associate II (CRA II) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and Rho Standard Operating Procedures.
This position requires proven monitoring skills. The CRA II conducts site visits to assess site adherence to protocol and regulatory requirements as well as manages required documentation. The CRA II will also be responsible for ensuring the data remains audit ready and able to pass an audit by Rho, the Sponsor or a regulatory agency.
The CRA II will be a part of a multi-disciplinary team that provides scientific, statistical, operations, and management support for commercially or federally funded clinical trials.
Required to travel is up to 80%. Applicants must live within a 60 minute commute of a US metropolitan airport.
The Senior Clinical Research Associate (Sr. CRA) role is integral to driving project success. This position will perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and Rho Standard Operating Procedures.
This position requires proven monitoring skills. The Sr. CRA conducts site visits to assess site adherence to protocol and regulatory requirements as well as manages required documentation. The Sr. CRA will also be responsible for ensuring the data remains audit ready and able to pass an audit by Rho, the Sponsor, or a regulatory agency.
The Senior CRA will be responsible for supporting study team management by providing input into monitoring tools and process development as well as training for newly assigned project CRAs.
Required to travel up to 80%. Applicants must live within a 60 minute commute of a US metropolitan airport.