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Grifols Shared Services North America, Inc Clinical Research Associate II in Durham, North Carolina

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Location : Durham, NC

T itle : Clinical Research Associate II

Requirements: Candidate must have a Bachelor or foreign equivalent degree Clinical Research Management/Administration, Biomedical Science, or a directly related field and 2 years of experience in plasma derived products. Must have experience in: regulatory requirements from the Food and Drug Administration (FDA) in the U.S. and the Conformitè Europëenne Mark(CE Mark) in the European Economic Area; Documentum Compliance Manager (DCM); utilizing SAP to report SOP deviations; investigating and resolving claims/questions from clients regarding blood/plasma related drugs or devices; performing User Acceptance Testing (UAT) of electronic systems used in blood plasma studies; and issuing and reporting queries for the improvement of electronic systems. The employer will accept any suitable combination of education, training, or experience.

Job Duties: Coordinate U.S. and Global Clinical Trials that address rare diseases, such as Post-Polio Syndrome and Emphysema, with plasma-derived products, including Human intravenous immune globulin G Flebogamma 5% DIF, Alpha1-Proteinase Inhibitor Subcutaneous (Human), and Liquid Alpha1-Proteinase Inhibitor (Human), using related medical terminology. Perform site monitoring to ensure sites participating in the Clinical Trials are compliant with company SOPs and regulatory requirements from the Food and Drug Administration (FDA). Reconcile clinical supplies and drug accountability records at study sites. Observe the site visits of contracted Clinical Research Associates (CRAs) and review site visit reports to identify potential issues at sites, providing advice to ensure proper site support. Act as sponsor representative, performing visits to participating sites to oversee the conduct of the study and discussing any concerns, questions, or any findings discovered during the visit with the Principal Investigators and their teams. Serve as point of contact for the Contract Research Organization (CRO). Manage contracted vendors that provide the medical devices necessary for sites to conduct the study assessments. Ensure devices are compliant with the Conformitè Europëenne Mark(CE Mark) in the European Economic Area and FDA regulations in the U.S. Support sites with the use of the medical devices provided. Oversee vendors providing Home Health Care services to ensure investigational drugs are administered at the homes of the subjects according to the Protocol and assessments and samples are collected. Create and review study documents, including Study Plans and informed consent forms for participating subjects. Review data listings collected from sites to identify issues and trends, as well as Protocol Deviations. Perform User Acceptance Testing (UAT) of the electronic systems used in the blood plasma studies. Issue and report queries for the improvement of these electronic systems to ensure they are built according to the requirements of the study. Collaborate with data management to resolve queries. Ensure coordination of an accelerated study start-up including pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study. Identify, screen, and qualify investigators through feasibility questionnaires and pre-study visits. Prepare key reports and documents study progress for the study manager. Investigate and resolve claims/questions from clients regarding blood/plasma related drugs. Perform regulatory document reviews and provide approval for Investigational Product release. Assist in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings). Review, create, and track trial newsletters, memos, mass correspondence, and other appropriate trial-related documentation. Participate in Electronic Data Capture system development, Interactive Web Response System set-up, central lab set-up, and other vendor selection processes. Communicate and interact with relevant study personnel. Develop and maintain collaborative relationships to manage study issues and support milestone achievement. Use Documentum Compliance Manager (DCM) to manage company and study specific documentation. Utilize SAP to report SOP deviations.


Req ID: 500431