Job Description - CMA II - Canada - Homebased (20009472)
CMA II - Canada - Homebased -(20009472)
The Central Monitoring Associate II (CMA II) will
perform remote monitoring and site management activities for Phase I-IV
clinical research and/or non-interventional studies (NIS) to assess the
progress of clinical projects at assigned sites and to ensure these projects
are conducted, recorded, and reported in accordance with the protocol, Company
and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all
applicable local and federal regulatory requirements.Performs all tasks routinely and
independently, seeking guidance as needed.
·Performs remote site qualification, site initiation, site
monitoring calls, and close-out visits ensuring regulatory, ICH-GCP and
protocol compliance.Uses judgment and
experience to evaluate overall performance of site and site staff and to
provide recommendations regarding site-specific actions; immediately
communicates/escalates serious issues to the project team and develops action
plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable
guidance, relevant regulations, and company SOPs/processes. May require
knowledge of Good Pharmacoepidemiology Practices (GPP) and Good Epidemiologic
Practices (GEP) guidelines for NIS and to adhere to a schedule of data
collection from HCPs and patients for NIS, effectively employing technology for
·Assesses the process of obtaining informed consent has been
adequately performed and documented for each subject/patient as
diligence in protecting the confidentiality of each subject/patient. Assesses
factors that might affect subject/patient’s safety and clinical data integrity
at an investigator/physician site such as protocol deviation/violations and
·Applies query resolution techniques remotely and provides
guidance to site staff as necessary, driving query resolution to closure within
agreed timelines. Utilizes available hardware and software to support the
effective conduct of the clinical study data review and capture. Assesses site
compliance with electronic data capture requirements.
·May perform Remote Aggregated Data Review (RADaR) utilizing
the appropriate tools to identify, respond and manage issues in line with the
associated Work Instructions (WI), RADaR guideline and Clinical Monitoring Plan
(CMP)/Site Management Plan (SMP) for assigned sites/project. Ability to
identify trends within and across sites, escalating issues and trends to develop
corrective actions / preventative actions.
·May assesses if investigational product (IP) has been
dispensed and administered to subjects/patients according to the protocol,
identifying if issues or risks associated with blinded or randomized information
related to IP have occurred. Applies knowledge of GCP/local regulations and
organizational procedures to ensure IP is appropriately (re)labelled, imported
·Routinely reviews the site section of the TMF or project
master file (PMF) in totality for accuracy, timeliness and completeness.
Requests new/updated documents from the site, as required. If remote access is
available to an electronic Investigator Site File (eISF), routinely reviews the
eISF for accuracy, timeliness and completeness. Reconciles contents of the eISF
with the trial master file (TMF). Ensures the investigator/physician site is
aware of the requirement of archiving essential documents in accordance with
local guidelines and regulations..
·Documents activities via confirmation letters, follow-up
letters, trip reports, communication logs, and other required project documents
as per SOPs and CMP/SMPSupports
subject/patient recruitment, retention and awareness strategies.Enters data into tracking systems as required
to track all observations, ongoing status and assigned action items to
·For assigned activities, understands project scope, budgets,
and timelines; manages site-level activities / communication to ensure project
objectives, deliverables and timelines are met.Must be able to quickly adapt to changing priorities to achieve goals /
·Acts as primary liaison with project site personnel or NIS
reporters, in collaboration with the on-site CRA.Ensures all assigned sites and project-specific
site team members are trained and compliant with applicable requirements.
·Prepares for and attends Investigator Meetings, Advisory
Committee Meetings and/or sponsor face to face meetings.Participates in global clinical
monitoring/project staff meetings (inclusive of Sponsor representation, as
applicable) and attends clinical training sessions according to the project
·Provides guidance at the site and project level towards audit
readiness standards and supports preparation for audit and required follow-up
·For Real World and Late Phase, the CMA I may be assigned to
the Registry Coordinating Center (RCC).Additional responsibilities include:
oData review, data query
resolution and direct data entry of Health Care Provider (HCP) and Patient
communications (inbound and outbound) with registry physicians, and/or
patients, by utilizing web-based tools and other communication tools to ensure
compliance with protocol requirements and relevant guidelines
oComplete chart abstraction
oProvide training to junior
oConsult with RWLP Regulatory
Advisory Services to maintain current information of local and regional
requirements for real world and late phase study designs.
degree or RN in a related field or equivalent combination of education,
training and experience
of Good Clinical Practice/ICH Guidelines and/or other applicable regulatory
demonstrate good computer skills and be able to embrace new technologies.Proficiency in navigation within CTMS systems
and Data Platforms for projects required
communication, presentation and interpersonal skills. Basic level of critical
thinking skills expected
to manage less than 25% travel
Tasks, duties, and responsibilities as listed in this job
description are not exhaustive. The Company, at its sole discretion and with no
prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and/or education will also be considered so
qualifications of incumbents may differ from those listed in the Job
Description. The Company, at its sole discretion, will determine what
constitutes as equivalent to the qualifications described above. Further,
nothing contained herein should be construed to create an employment contract.
Occasionally, required skills/experiences for jobs are expressed in brief
terms. Any language contained herein is intended to fully comply with all
obligations imposed by the legislation of each country in which it operates,
including the implementation of the EU Equality Directive, in relation to the
recruitment and employment of its employees.
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