When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Accountabilities:
Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation andrecruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
Support database release as needed
May undertake the responsibilities of an unblinded monitor where appropriate
Clinical/Scientific and Site Monitoring Risk
Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
Interact with investigator site heath care professionals in a manner which enhances the client’s credibility, scientific leadership and in order to facilitate the client’s clinical development goals
Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
Drive Quality Event (QE) remediation, when applicable
Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable
Collaboration
Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM)
Partners with SCP and Country Study Operations Manager (SOM)
When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist)
May act as a Mentor for Clinical Research Associates
Compliance with Parexel standards
Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates curriculum vitae (CV) as required
Maintains a working knowledge of and complies with Parexel processes, International Conference on Harmonization (ICH) - GCPs, and other applicable requirements
Skills:
Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Knowledge and Experience:
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)
Demonstrated ability to support sponsor regulatory interactions/inspections
Demonstrated knowledge of the processes around protocol design and feasibility assessment
Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery
Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial
Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
Education:
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent