Medical Monitor
Company: Alimentiv
Location: Miami
Posted on: May 16, 2022
|
|
Job Description:
POSITION LOCATION: United States (home-based)POSITION TITLE:
Medical MonitorPOSITION REPORTS TO: Sr. Medical MonitorJOB
SUMMARY:This role is intended to provide unbiased, 24/7, medical
guidance to clinical sites and study operations teams. The medical
monitor provides therapeutic and compound training, medical
guidance on protocol compliance and coding of medical terms. The
medical monitor supports clinical safety and data management by
reviewing data listings. The medical monitor may also assist with
the writing of the final study report. The medical monitor provides
regular communication to the medical team (including medical
teleconferences), and interfaces with sponsor Medical groups
throughout the study.AREAS OF RESPONSIBILITY:Medical Oversight
Provide clarity on general protocol questions, and medical guidance
for protocols as required. Serve as medical expert providing
guidance on patient eligibility matters, and investigational
product related questionsDocument contacts in accordance with
Robarts or study specific procedures.Consult with Robarts Medical
Director(s), Sponsor Medical group and/or Safety with regard to
medical questions pertaining to the indication under study.Quickly
identify safety issues as appropriateProvide consultation on the
unblinding of trial participants/site staff to subject treatment
allocationReview individual, out of range laboratory values
following study-specific laboratory guidelines and alert values (as
appropriate)Review protocol deviation data and recommend protocol
changes as appropriateFollow a study-specific medical monitoring
plan if applicableProvide medical review of study level data, to
identify gaps and areas requiring additional safety-related
follow-upParticipate in the development, review and finalization of
protocols, amendments, Clinical Study Reports, as requiredProvide
medical input into data collection tools, study plans (e.g.,
monitoring, statistical analysis plans, etc.Provide medical input
into study feasibility, site selection and site initiations as
requiredAttend and lead medical monitoring teleconferences at
regularly scheduled intervals throughout the study, if
requiredKnowledgeMaintain a thorough working knowledge of
protocol(s) and the current Investigator Brochure(s) with
particular attention to those aspects relating to safety data
involving human subjectsTraining Provide internal training to
Alimentiv's operational teams on specific diseases, drug targets,
pharmacology, protocol requirements etc, as needed to support
execution of client studiesAssist with the development of
investigator training and meeting support materials.Attend and
present at investigator meetings and CRA training
meetings.QUALIFICATIONS:Applicants should have a minimum of a
Medical Degree (MD) and 3-5 years of relevant experience with
significant job-related training. Further, the successful candidate
will possess strong written and verbal communication and
presentation skills, enabling effective interactions with team
members within Alimentiv, client company personnel and prospective
sponsors. Advanced understanding of drug development process, ICH
and Good Clinical Practices (GCP) is required. WORKING CONDITIONS:
Home-based10-15% travel*Accommodations for job applicants with
disabilities are available upon request.#LI-Remote
Keywords: Alimentiv, Miami , Medical Monitor, Healthcare , Miami, Florida
Click
here to apply!
|