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Sr. Clinical Research Associate
Location : California, Santa Clara
Refer job # EMDP340796
Job Responsibilities and Requirements: The senior clinical research associate (SCRA) designs, implements, and monitors clinical studies of new and modified in vitro diagnostic products. Ensures that the clinical studies are designed to validate product performance claims and support the products intended use. Prepares clinical data reviews and data summaries. Participates in the preparation of regulatory submissions and international registration packages. Manages a single large project, a more complex project, or several smaller related projects. The SCRA has established a high degree of competence in clinical research. The SCRA 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. Main Responsibilities Actively participates as a member of the cross-functional project team. - Participates in assessing performance data generated by R&D/Business Teams prior to initiation of the clinical study. - 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.Serves as a consultant in a select area of expertise., Clinical monitoring responsibilities include: - Prepares design validation plans that meet product design goals, intended use, regulatory requirements, divisional operating procedures, and Clinical Research work instructions.Prepares clinical protocol, clinical brochure, case report forms, informed consents, and other required documents for clinical studies. - Identifies and qualifies clinical investigators and clinical sites. Proposes and negotiates budgets for clinical studies.Initiates payments to sites. Obtains and reviews all required essential documents necessary for study initiation. Initiates clinical studies and provides for investigator and staff training. Arranges for and assists Statistical Support with the collection and statistical analyses of clinical data.Monitors clinical studies, ensuring site compliance with the clinical protocol and ICH/GCP guidelines, assures subject rights, safety, and welfare are protected, ensures data integrity through completeness, accuracy, and legibility. Conducts pre-study, initiation ,interim, and close-out monitoring site visits and completes site visit reports.Maintains accurate and timely sponsor/site correspondence and communication. Responsibilities for preparing Clinical Research reports/presentations include: - Prepares and presents project progress reports to keep management and team informed. Reviews data, prepares and presents clinical data reviews and data summaries. Responds to audits and data queries representing a project or team.Prepares standard the clinical sections of regulatory submissions and international registration packages. Prepares and reviews product labeling and promotional materials.Coordinates preparation of responses to regulatory agencies questions regarding the clinical study. Assists in presentation of clinical information to the FDA.Initiates standard publication or presentation of clinical data in professional journals or meetings. Prepares publications, abstracts, or presentations for professional meetings with minimal assistance. Additional responsibilities: - Functions independently in the field and interacts with all levels of medical and scientific professionals.May advises and trains newly hired CRAs and direct others in the completion of tasks and projects.Maintains professional, product, and market expertise via independent reading, networking, and training. Assumes responsibility for attending training sessions, presentations, and continuing education sessions to expand professional expertise via professional and educational opportunities. Serves as a resource person for most technical questions or directs inquiries to appropriate references.Volunteers for task forces, manages projects, or serves as a group leader.Encourages collaborative behavior, delegates effectively, and empowers others to take action.Gives effective feedback. Acts with fairness.Actions and words are congruent. Accepts and completes all management-directed work assignments such as clinical assignments, travel, and other tasks.Demonstrates good presentation skills (i.e. clear, concise, effective, and well-organized),Tries to understand changes in work tasks, situations, and environment as well as the logic or basis for change. Accountability/Job Scope:Successful and timely completion of clinical studies directly impacts the ability to meet product market entry dates. Early identification of unsatisfactory results, operations, or specific problems allows immediate action to be taken by appropriate groups. Resolution of problems and timely data analysis is critical to meeting the scheduled goals of the project. Accountable for the project scope and scheduled completion date. Works under general management direction. Participates in professional activities in the US and/or Internationally. Qualifications: Minimum Bachelor Degree required. B.S. in biological science or medical specialty preferred. Other: Clinical Laboratory Certification MT(ASCP) or CRA (CCRA) desirable. Knowledge of regulations and standards affecting GCP,IVDs or Biologics required Minimum of 5 years clinical related experience, of which at least 2 clinical research monitoring with strong site management and monitoring skills or minimum of 5 years laboratory experience with IVDs, reviewing data and data analysis and applicable automated diagnostics instruments (e.g., CELL-DYN Sapphire, Alinity h-series ).
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