Clinical Affairs Coordinator - United States
Provide support to new assay/product development and clinical studies by coordinating and compiling the clinical data, perform administrative tasks as part of clinical project teams to support the completion of clinical trial/regulatory documentation and processes. Supports applicable regulations including ISO, Local, State, and/or Federal requirements.
- Build and maintain clinical regulatory binders for clinical sites
- Maintain clinical sample and device accountability; including shipments and logs
- Maintain clinical study databases for internal and external clinical sites. Identify data discrepancies and query sites as appropriate.
- Coordinate and manage regulatory binder, monitoring and data queries with CRO, as appropriate
- Ensure GCP study conduct throughout the study.
- Coordinate and file study and site document archives
Train and work with internal and external team members, as requested
- Performs other duties as assigned
Qualifications Experience Personal Strengths Mobility
- Competent in software such as Excel, Access, Word.
- Basic laboratory experience and safety understanding preferred
- FDA experience and familiarity with regulations around FDA preferred
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Ability to write routine reports and correspondence.
- Ability to add and subtract two digit numbers and to multiply and divide with 10’s and 100’s.
- Ability to perform these operations using units of American money and weight measurements, volume, and distance.
- Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
- Ability to deal with problems involving several concrete variables in standardized situations.
As per local and Company requirements for DiaSorin, Inc.
Others Information as per Local Legal Requirements
Must be 18 years of age, legally authorized to work in the US; and not require sponsorship for employment visa status (e.g, TN, H1B status) now or in the near future.
It is the policy of DiaSorin to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, DiaSorin will provide reasonable accommodations for qualified individuals with disabilities. Our company uses E-verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
DiaSorin is an EEO/AA employer.
EEO is the Law | http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf