Rti international (rti) is one of the world`s leading research institutes, dedicated to improving the human condition by turning knowledge into practiceOur staff of more than 4000 provides research and technical services to governments and businesses in more than 75 countries in the areas of health and pharmaceuticals, education and training, surveys and statistics, advanced technology, international development, economic and social policy, energy and the environment, and laboratory testing and chemical analysis.
The center for clinical research network coordination (crnc) in the biostatistics and epidemiology division of rti is currently seeking an experienced clinical research managerCrnc provides statistical leadership and support of pre-clinical research, clinical trials, and observational studies, including expertise in statistical design, implementation, and analysisThis position to be based in any domestic office at rtiTelecommuting will be considered on a case-by-case basis.
Please include a cover letter as the first page of your resume or attach as a separate document to your application.
Essential duties:
Provide technical support to clinical research projects
Prepare and distribute study documents and materials including data collection forms, manuals of operations and technical memos to research sites
Prepare and update monthly progress reports
Prepare and review irb materials for the rti irb, central irbs and for the clinical research sites
Prepare training materials; participate in and/or lead trainings for clinical site staffs
Collaborate with data management team to develop and implement data collection and management strategies
Assist study sponsor in assuring that the research site personnel are conducting the study according to the clinical protocol, `good clinical practices,` and regulatory requirements
Monitor adverse events submitted by research site staff for reporting to the sponsor
Review accuracy and completeness of site records (site study file, crfs and other data collection tools, source data)
Apply a working knowledge of gcp, cfr 21 and 45
Participate in quality control activities and implement quality assurance activities
Contribute to clinical study reports
Write safety monitoring plans
Prepare adverse event forms for regulatory submission
Manage project budgets and client deliverables
Support the establishment of subcontract for study services (i.e., drug procurement)
Conduct on-site/remote monitoring visits at clinical research sites
Collaborate on multidisciplinary teams in the development of proposals
Write proposal sections requiring application of clinical research management and project management principles
Work on protocols of increasing complexity, such as ind and ide protocols or multi-site protocols
Participate in training and orientation of new clinical study specialists and act as a resource for new hires
Qualifications:
Bachelor’s degree in health related field and 8 years’ related experience; master’s degree and 6 years’ related experience; postdoctoral degree and 1 years related experience; or equivalent combination of education and experience.
Excellent oral and written communication skills (cover letter required)
Ability to work successfully on multidisciplinary teams
Ability to manage multiple projects simultaneously
Experience with clinical site management, regulatory submissions, and clinical data
To qualify, applicants must be legally authorized to work in the unites states and should not require now, or in the future, sponsorship for employment visa status
Desired qualifications
Ccrp (or equivalent) certification a plus
Staff management experience
Budget development experience
The anticipated pay range for this role is between $90,000-$110,000.
Rti considers multiple factors when making an offer including, for example: established salary range, internal budget, business needs, and education and years of work experience possessed by the applicantFurther, salary is merely one element to our offer.
At rti, we demonstrate our commitment to rewarding individual and team achievement through a total rewards packageThis package includes (among other things) a competitive base salary, a generous paid time off policy, merit based annual increases, bonus opportunities and a robust recognition programOther benefits include a competitive range of insurance plans (including health, dental, life, and short-term and long-term disability), access to a retirement savings program such as a 401(k) plan, paid parental leave for mothers and fathers, financial assistance with adoption expenses or infertility treatments, financial reimbursement for education and developmental opportunities, an employee assistance program, and numerous other offerings to support a healthy work-life balance.
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