Senior Clinical Research Associate I - Remote Field-based

Pfizer; United States; Remote; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Pfizer is seeking a Senior Clinical Research Associate I to manage investigator site activities, monitor trials, and ensure patient safety and data integrity across assigned sites. You will partner with the Site Care Partner and study team to drive enrollment, site quality, and compliance with ICH/GCP and Pfizer standards.

Responsibilities include onsite and remote monitoring, site training, and timely reporting.

Qualifikationen

• Bachelor's degree in life sciences or equivalent required.
• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations.
• Fluency in English and local language where applicable.

Aufgaben

• Manage investigator site monitoring from initiation through database lock.
• Primary contact for investigator sites; coordinate with SCP to ensure site delivery quality.
• Interface with study team to facilitate information flow between vendors and sites.
• Develop and train site personnel to ensure protocol compliance and patient safety.
• Attend investigator meetings (virtual or in person) as required.
• Provide enrollment support and assist with recruitment initiatives at the site level.
• Conduct onsite and remote monitoring per plan and SOPs.
• Monitor AEs/SAEs and follow up to resolution with Drug Safety Unit.
• Submit Trial Master File docs, site reports, and progress updates on timeframes.
• Identify and resolve site issues; implement corrective actions and prevent recurrence.
• Resolve data queries; plan and execute site close-out activities.
• Oversee investigational product receipt, storage, and destruction at sites.
• Support database releases; may serve as unblinded monitor when needed.

Kenntnisse

Clinical monitoring

ICH/GCP knowledge

FDA regulations

English fluency

Ausbildung

Bachelor's degree in life sciences or equivalent

Jobbeschreibung

Pfizer is seeking a Senior Clinical Research Associate I to manage investigator site activities, monitor trials, and ensure patient safety and data integrity across assigned sites. You will partner with the Site Care Partner and study team to drive enrollment, site quality, and compliance with ICH/GCP and Pfizer standards.

Responsibilities include onsite and remote monitoring, site training, and timely reporting.