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Clinical Research Associate Job Description
Job Posting: January 30, 2008
Romark Laboratories, L.C., is a privately held specialty pharmaceutical company focused on developing, manufacturing and commercializing Infectious
Diseases products. Romark offers an excellent work environment, competitive compensation and benefits, including 401-k, employee share appreciation plan.
If you would like to become a member of a highly dynamic and successful team, and enjoy working in an entrepreneurial environment, then you must submit
your resume.
Job Responsibilities:
Monitors the monitoring activities of assigned clinical trials for the company's products to ensure adherence to Federal regulations, company policies,
and any other applicable procedures. Acts as project resource to study site regarding the product under test and the clinical trial conduct.
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Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of
investigators/study coordinators, conducting on-site evaluations and follow-up of corrective actions.
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Ensures validity of study information by monitoring and tracking clinical study data (CRFs, source documents, diagnostic reports, inventory logs, etc.)
to identify/resolve discrepancies and obtain missing data.
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Identifies, evaluates, properly reports and ensures adequate follow-up of adverse experiences by timely and accurate documentation and appropriate
communication of all Adverse Event reports per internal procedures and regulatory requirements.
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Contributes to writing case report forms, and other study aids for investigational products by addressing issues from a monitoring perspective.
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Maintains expertise in regulations for all geographies and types of studies. Serves as a resource related to clinical trial regulations.
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Serves as a mentor for new employees.
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Ensures timely collection of study documentation by obtaining, maintaining and controlling all necessary records and documentation according to
procedures and regulations.
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Ensures proper product supply, accountability and storage during assigned clinical studies by ordering investigational product per procedure,
reviewing product usage reports, resolving any discrepancies and inspecting clinical site device accountability records and storage.
Qualifications:
Bachelor's degree plus 3-5 years of related work experience in the field of clinical research. Excellent verbal, written, interpersonal and presentation skills
are required. Must be familiar with routine medical/scientific terminology. Must be familiar with Word, Power-Point, and excel and knowledge of FDA regulations.,
ICH guidelines, and GCPs governing the conduct of clinical trials.
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