job title sr clin res assoc
job family clinical
job category full-time
job classification experienced/established
division abbott molecular diagnostics
relocation assistance none
at abbott, we provide the perspectives and experience necessary to translate science into real solutions for patients in over 130 markets worldwide.
advises and supports newly hired cras with department procedures.
participates in assessing performance data generated by r&d/business teams prior to initiation of the clinical study.prepares, and presents clinical data reviews and data summaries,
actively participates as a member of the cross-functional proejct team.today, abobtt\'s nearly 90, 000 employees are doing work that matters.
assists regulatory in preparing responses to regulatory agencies\' questions regarding the clinical study.through our diverse healthcare businesses, we connect people and potential in ways that no otehr company can.case report forms,
prepares clinical protocol, and other required documents for clinical studies, clinical brochure, informed consents.our employees are given the tools to succeed, with challenging opportnuities and work that makes a difference, lead and grow.accountable for the project scope and scheudled completion date.
knowledge of regulations and standards affecting ivds and biologics.masters degree is preferred, or equivalent clinical research experience of 8 to 9 years, a. or b.s. in the biological sciences.
prepares the clinical sections of regulatory submissions and interntaional registration packages.
functions independently in the field and interacts with all levels of medical and scientific professionals.
collaborates with statistical support with the collection and statistical analyses of clinical data.
certification requierments medical technology mt(ascp) or equivalent, or certification as a clinical research associate (ccra) is desirable.we believe that diversity drives innovation,
at abbott.safety, accuracy, ensuring site compliance with the clinical protocol and ich/gcp guidelines; assures subject rights, and welfare are protected; ensures data integrity through completeness,
monitors clinical studies, and legibility.works under the direction of the clinical project manager.procedures, and good clinical practice (gcp), ensures that the clinical studies are conducted per established policies, regulations.
maintains professional, product, and market expertise via independent reading, networking, and training.
skills/experience requirements basic qualifciations:
knowledge of regulations and standards affecting ivds and biologics.
accountability / scope:
successful and tiemly completion of clinical studies directly impacts the ability to meet product market entry dates. participates in the preparation of regulatory submissions and international registration packages.
prepares and presents project progress reports to keep management and team informed.initiates payments to clinical sites.abbott is regarded as an employer of choice for our commitment to workplace excellence, il
employer of choice
through numerous local, national and international accoaldes,
signfiicant work actiivties & condtiions work with huamn blood or other potenitally infetcious mateirals
pecrent of trvael 50+ %
conutry untied sttaes
stie loctaion des planies.resoultion of prolbems and timely data anaylsis is criitcal to meeitng the scheduled golas of the project.
eduaction requirements b.
disocver a wolrd of opportunities at abbott.
resopnds to auidts and data queries.
proposes and negotiates budgets for clinical studies.
identifies and qualifies clinical investigators and clinical sites.innovative thinkers who are passionate about the work they do, abbott employees are representative of the diversity of the patients we strive to serve every single day across the globe.
acquires a basic understanding of the principles of the assay and/or instrument and \"hands-on\" knowledge and skills in performing assigned assays or operating instruments.intended use, and clinical research work instructions, regulatory requirements,
prepares clinical plans that meet product design goals, divisional operating procedures.
obtains and reviews all required essential documents necessary for study initiation.has obtained prior exposure to all aspects of a clinical study and functions at a proficient level of independence with a significant degree of autonomy in conducting clinical research
responsible for implementing and maintaining the effectiveness of the quality system.
suggests improvements for increased departmental efficiency.
maintains accurate and timely sponsor/site correspondence and communication.and regulations related to clinical research, established procedures,
complies with all policies.and participation in professional activities outside of normal business hours, ability to travel (50-80% us and/or international), familiarity with desktop computer office software,
minimum of 6 years relevant professional experience including:
clinical research 2 to 3 years
laboratory (hospital, research, industrial) 3 to 4 years
quality assurance/auditing 1 to 2 years
customer contact 1 to 2 years
other: this position requires good oral and written communication skills.
conducts pre-study, interim, and closeout monitoring site visits and completes site visit reports, initiation.a complex project, works with minimal supervision on a single large project, or several smaller projects.and monitors clinical studies of new and modified in vitro diagnostic products, implements,
job description primary function / primary goals / objectives:
the senior clinical research associate (scra) designs.has established a high degree of competence in clinical research. operations, or specific problems allows immediate action to be taken by appropriate groups, early identification of unsatisfactory results.
may perform other duties as assigned.assay/instrument principles involving in vitro diagnostic product design and usage, regulatory, and the scientific, statistical, and compliance requirements for conducting clinical research,
this position requires an understanding of the clinical laboratory.