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Job Title: Analista de Pesquisa Clínica Sr
Job Location: Brazil - São Paulo
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
The Senior Clinical Research Associate I is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices, and Pfizer standards.
The Senior Clinical Research Associate I role is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company’s image with its external stakeholders.
The Senior Clinical Research Associate I is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner, and other members of the study team, as required, in activities associated with the set-up, running and close out of sites in a clinical trial.
JOB RESPONSIBILITIES:
Responsible for investigator site management and monitoring for assigned sites: Clinical Trial Monitoring:
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and
applicable prevailing laws, Good Clinical Practices, and Pfizer standards to achieve project goals, timelines and quality.Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site initiation 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 meetings when required (virtual or F2F).
Provide enrollment support and ensure progress by responding to site activation and recruitment 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 Study Monitoring Plan, SOPs and commensurate with emerging issues and technologies.
Monitor site level AEs and 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 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 required.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 Pfizer’s credibility, scientific leadership and in order to facilitate Pfizer’s clinical development goals
Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
Drive Quality Event remediation, when applicable
Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable. Other:
Mentor/train Clinical Research Associates as assigned Serve as an SME for CRA-related processes Participate in regional or local working groups/process improvement initiatives Perform activities under guidance of a Site Care Partner prior to site activation e.g. feasibility and site selection, PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation Conduct co-monitoring activities as requested.
QUALIFICATIONS:
medical background or equivalent
Extensive knowledge of clinical trial methodologies, ICH/GCP, 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.
PHYSICAL/MENTAL REQUIREMENTS :
Advanced knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Advanced understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
Advanced 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
Proven 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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS: Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid passport required.
ORGANIZATIONAL RELATIONSHIPS : Partners with Site Care Partner and Country SOM
Reports to Director of Clinical Site Operations, or Director of Site Management and Monitoring, or Site Care Partner III in some countries
When required Partners with other Study Team members e.g. Clinician, Recruitment Specialist, Clinical Data Scientist
Act as a mentor for Clinical Research Associates
Partner with other functional lines if engaged in a workstream/ LDT/ SME role.
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