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WHAT
IN
Clinical Research Monitor
Job
Medtronic
US
-
Phoenix,
Arizona
Job Code - 68013
Position - Full Time - Regular
Job First Active on: Tuesday, October 27, 2009
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JOB DESCRIPTION: Clinical Research Monitor
The Clinical Research Monitor is responsible for overseeing the conduct of Spinal and Biologics clinical studies. This position is responsible for performing on-site monitoring activities to ensure assigned clinical studies are conducted in accordance with approved protocols, applicable regulations, work instructions, guidelines and/or policies. The clinical monitor develops and maintains liaison among outside physicians and clinical investigators, Clinical Research Organizations (CRO's), affiliated hospitals, state and/or government hospitals, and research institutions to initiate and expedite clinical studies on products that have investigation device exemption (IDE) requirements, investigational new drug (IND) requirements or special provisions as required by the FDA for 510k approval. Contacts and recommends qualified investigators to perform studies, prepare exhibits, and provide scientific and medical consultations for any phase of development studies. The clinical research monitor is responsible for reviewing cases with investigators, determining and monitoring time schedules, and issuing status reports. Assists with design, development, and monitoring of clinical evaluation projects and associated monitoring plans. Additionally, the clinical research monitor will train investigators and associated personnel on the conduct of the clinical trials they are involved.
The proposed region for new monitoring position would be in the West/Central part of the US (Arizona/Texas/Utah/Nevada/Colorado/New Mexico)
REQUIREMENTS - QUALIFICATIONS: Clinical Research Monitor
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned:
Performs pre-study site qualification visits to evaluate adequacy of site, investigator and designated site personnel.
Performs ongoing monitoring visits at assigned investigational sites to verify that the rights and well being of human subjects are protected and the reported clinical data is accurate, complete and verifiable from source documents.
Performs close-out visits as well as other activities associated with the completion of a clinical trial.
Participates in the site nomination process; perform evaluation of site capability to deliver the contractually agreed to number of patients and high quality data then make recommendation for inclusion in the clinical trial.
Reviews records to ensure clinical studies are conducted in compliance with currently approved protocols, applicable regulations, work instructions, guidelines and/or policies.
Ensures site compliance with the clinical study protocol, documentation and resolution of monitoring issues, safety, investigational product accountability/accuracy, preventative/corrective action plan implementation to prevent recurrences.
Assist in query writing and resolution process, as required.Ensures study documentation is accurately and properly maintained at investigational sites.
Provides on-site training of investigators and other site personnel.
Prepares and submits timely, accurate and complete monitoring reports.
Collaborates with cross-functional teams in evaluation of safety data, investigational product tracking, compliance, data management, etc.
Communicates with internal clinical study team to assure adherence to timelines for site monitoring and clinical study activities.
Communicates with clinical sites to expedite the exchange of information and assure that clinical studies are kept on schedule.
Maintains a high level of professional expertise through familiarity with clinical literature and participation in clinical team meetings.
Coordinates the organization of study files, inventory and all related study materials.
Ensures that clinical sites have adequate supplies of product and material to effectively conduct the study.
May occasionally prepare materials and deliver presentations at investigator and general clinical meetings.
May occasionally assist with preparation of progress reports for clinical studies.
May occasionally assist the clinical management staff with the development, approval, and distribution of study-related documents including Case Report Forms (CRFs), study protocols, study manuals, and other study tools to investigational sites and review committees, as applicable.
May occasionally assist with preparation of documents for obtaining product or study approvals such as IDE application, IND application, FDA reporting, etc..
Attends and/or performs site initiation visits as needed.
May occasionally assist with financial aspect of the clinical trial including: contracts, budget negotiations and preparations as needed.
May occasionally assist with supplying content for mass communications, newsletters, and study coordinator training/conferences, etc., as needed.
Participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed.
May occasionally assist with the development and/or maintenance of the clinical infrastructure such as the drafting or reviewing Best Practices and Work Instructions.
Assists in various projects as assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and EXPERIENCE REQUIREMENTS:
Bachelor’s degree, preferably in a life science or scientific related field, or RN or BSN degree and two years experience in clinical trials and site coordination (industry/institutional setting preferred). Knowledge of FDA regulatory requirements required.
Medtronics
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