Site Monitor / CRA - US Northeast or Pacific Northwest - FSP
Parexel
Durham, NC
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Job Summary
The Site Monitor will be responsible for data integrity, data quality and ensuring compliance with International Council for Harmonization and Good Clinical Practice (ICH GCP) and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on site visit requirements. The Site Monitor I will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready, will coordinate with institutions and investigators at the local level, and will collaborate with the Study Operations Manager (SOM), Global Study Manager (GSM), and Site Care Partner (SCP).
Key Accountabilities
Oversight of Monitoring Responsibilities and Study Conduct:
within agreed timelines
blinded or randomized information related to IP
released and returned
and CMP and SMP
ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals and targets
log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study, review and assess training compliance with any new and updated training requirements (i.e., protocol amendment(s), etc.)
their expiry dates (as applicable)
Duties Log, Subject Identification Code List, IP Accountability Log)
Collaboration
training sessions according to the project specific requirements
Process, Standards, And Oversight
Skills
The Site Monitor will be responsible for data integrity, data quality and ensuring compliance with International Council for Harmonization and Good Clinical Practice (ICH GCP) and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on site visit requirements. The Site Monitor I will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready, will coordinate with institutions and investigators at the local level, and will collaborate with the Study Operations Manager (SOM), Global Study Manager (GSM), and Site Care Partner (SCP).
Key Accountabilities
Oversight of Monitoring Responsibilities and Study Conduct:
- Ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment
- Verifies the process of obtaining informed consent has been adequately
- Demonstrates diligence in protecting the confidentiality of each subject
- Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct
- Conducts source document review and verification of appropriate site
- Verifies required clinical data entered in the Case Report Form
- Manages reporting of protocol deviations and appropriate follow up
- Applies query resolution techniques remotely and on site, and provides
within agreed timelines
- Utilizes available hardware and software to support the effective
- May perform Investigational Product (IP) inventory, reconciliation and
- Verifies the IP has been dispensed and administered to subjects
blinded or randomized information related to IP
- Applies knowledge of GCP and local regulations and organizational
released and returned
- Manages reporting of identified issues and manages follow up to
- Documents activities via follow up letters, monitoring reports,
and CMP and SMP
- Ensures all activities are managed by site personnel who are
- Enters data into tracking systems as required to track all observations,
- For assigned activities, understands project scope, budgets, and
ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals and targets
- Reviews data entry timeliness in line with outlined requirements, missing
- Reviews site signature sheet and delegation of duties log to confirm any
log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study, review and assess training compliance with any new and updated training requirements (i.e., protocol amendment(s), etc.)
- Conducts follow up for escalated adverse event monitoring (AEM) report
- Checks the site and external facilities, equipment and supplies (clinical
their expiry dates (as applicable)
- Checks site specific logs are complete and up to date (e.g., Site Visit
Duties Log, Subject Identification Code List, IP Accountability Log)
Collaboration
- Collaborates with primary Site Manager who will act as the primary
- Prepares for and attends Investigator Meetings and sponsor face to face
- Participates in global clinical monitoring and project staff meetings
training sessions according to the project specific requirements
Process, Standards, And Oversight
- Provides guidance at the site and project level towards audit readiness
Skills
- Networking and relationship building skills
- Ability to communicate effectively and appropriately with internal and external stakeholders
- Ability to adapt to changing technologies and processes
- Effectively overcoming barriers encountered during the implementation of new processes and systems
- Excellent communication (verbal and written), presentation, and interpersonal skills relating to colleagues and associates, both inside and outside of the organization
- Identifies and builds effective relationships with investigator site staff and other stakeholders
- Must demonstrate good computer skills and be able to embrace new technologies
- Proficiency in local language is required
- English proficiency is required
- Ability to manage required travel of up to 75% on a regular basis
- A minimum of 1 year experience as a clinical monitor / clinical research associate with demonstrated experience of on-site monitoring
- Experience of utilizing systems like Siebel Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) (Florence) OR can demonstrate skill sets that show they have agility to work with new systems to support monitoring practice
- Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
-
Seniority level
Entry level -
Employment type
Full-time -
Job function
Other -
Industries
Pharmaceutical Manufacturing
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