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29 days old

Medical Monitor

Kelly Services
San Diego, CA 92108
Kelly Scientific is searching for a **Medical Monitor** with experience in Experimental Medicine, specifically Neuroscience, for a customer in beautiful San Diego, CA. You will be part of a dynamic clinical team providing medical expertise and medical oversight for the entire clinical trial, from initial study design through final study close-out.


+ Job Title: Medical Monitor in Experimental Medicine (Neuroscience)

+ Location: San Diego, CA

+ Duration: 1yr

+ Rate: $54-64/hr.


**ESSENTIAL FUNCTIONS:**


+ Responsible for all medical and safety aspects for the assigned neuroscience early development study(s)

+ Responsible for medical monitoring/reporting and evaluation of adverse events in early development clinical trials.

+ Act as the liaison between the clinical team and investigational site for all safety related aspects.

+ Provide safety/medical interpretation and reporting of clinical research results.

+ Takes responsibility for the safety/medical aspects of the trial protocol and clinical study reports.

+ Close interactions with Clinical Leaders and Clinical Scientists across studies.


**OTHER RESPONSIBILITIES / DETAILED DUTIES:**


+ Contribute to the development of the Clinical Trial Protocol, the Informed Consent and the Risk benefit document, possible amendments and other submission or regulatory documents within the specified timelines.

+ Review (e)CRF and other data collection tools to ensure that all necessary data are collected as requested per Clinical Trial Protocol.

+ Contributes to the creation of a major protocol deviation list

+ Develops an appropriate Medical Review Plan that allows study related safety follow-up in a timely manner.

+ Provides input in site selection when applicable.

+ Supports the clinical team for Investigator Meetings, Site Initiation Visits and Trial and Compound trainings.

+ Reviews and assess in a timely manner in- and exclusion criteria, adverse event of other safety questions.

+ Provides the Clinical Leader, the Molecule Responsible Physician and the Medical Safety Officer with regular updates on daily safety follow-ups of the assigned clinical trial (including Serious Adverse Event reporting)

+ Contributes to dose escalation meetings, cross functional team meeting working group meetings or other relevant trial meetings.

+ Liaises with investigational sites, clinicians as necessary.

+ Reviews and corrects where needed in a timely manner the Medical Coding and concomitant medication lists.

+ Contributes to and review Topline Results, Clinical Study Report, Plain Language Summary, Clinical Trial Registry

+ Contributes to the development and improvement of departmental procedures and processes and templates in the scope of the companys effort towards continuous quality improvement


**Education:**


+ MD in relevant area with appropriate training and certification Qualification

+ Experience in medical monitoring of clinical trials, trial execution and regulatory filing is required.

+ At least 3 years of industry experience (or equivalent) in clinical research that has exposed

+ the individual to the rigors of human trial conduct with pharmaceuticals or medical devices.

+ Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings is required.

+ Previous experience working on Clinical Trial and/or Compound Development Teams in a matrix management organization is desirable.

+ Willingness and ability to partially adjust work hours to facilitate trans-Atlantic collaboration.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-09-17 Expires: 2021-10-18

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Medical Monitor

Kelly Services
San Diego, CA 92108

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