Senior Clinical Research Associate I

Pfizer; India; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Pfizer is seeking a Senior Clinical Research Associate I to oversee investigator sites across the trial lifecycle, ensuring patient safety and quality execution in line with GCP and Pfizer standards. The role emphasizes site management, monitoring, and close-out, coordinating with the study team and SCP.

You will conduct site initiation, routine monitoring, and close-out, support enrollment, manage site relationships, and ensure timely documentation across the study Master File and reports.

Qualifications

• Experience in investigator site management and monitoring.
• Knowledge of GCP and regulatory requirements.
• Ability to coordinate with cross-functional teams and external sites.

Responsibilities

• Responsible for investigator site management and monitoring for assigned sites: Clinical Trial Monitoring.
• Ensure proper conduct of clinical trials in accordance with laws, GCP, and Pfizer standards.
• Manage timelines and quality from site initiation to database lock.
• Serve as primary contact for investigator sites and coordinate with SCP and study team.
• Provide site development, coaching and training to ensure protocol compliance and patient safeguarding.
• Attend investigator meetings when required and support recruitment initiatives.
• Conduct onsite or remote monitoring and ensure documentation and site reports are completed on time.
• Identify and resolve investigator site issues and develop corrective actions.
• Resolve data queries and conduct close-out activities per timelines.
• Oversee investigational product handling at sites and support database release.
• May undertake unblinded monitoring tasks when required.

Skills

Site management

Study monitoring

GCP compliance

Relationship management

Communication

Problem solving

Job description

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 Description:

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 elevate 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.
• 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 Si