Site Care Partner II

This is a fully remote position, open to applicants in New York, +1 more state.

📋 Description

• Act as the primary contact for investigative sites throughout the entirety of the study lifecycle.

• Oversee activities related to site start-up and activation.

• Qualify and activate designated sites by utilizing GSSO site strategies.

• Assist in the selection of countries and sites, as well as feasibility strategy, analytics, and protocol feasibility activities.

• Provide input from a country/regional perspective on country strategy, feasibility, protocol design, and outreach surveys.

• Coordinate items on the site activation checklist, finalize the ICD, conduct SIV activities, handle documentation, systems, and resolve issues.

• Ensure site initiation training, readiness, and follow-up activities through the first subject's first visit.

• Collaborate with CRA/Site Monitor to ensure readiness for monitoring and to support relationships with investigators.

• Offer study support for escalated site delivery issues, including those related to vendors, contracts, and payments.

• Manage strategies for investigational products and ancillary supplies throughout the study lifecycle.

• Plan and assist in site recruitment and enrollment activities.

• Work in coordination with local regulatory and clinical trial operations stakeholders.

• Build and maintain relationships with site organizations and strategic partners.

• Support the conduct of studies, review site reports, perform annual SMO assessments, and engage in close-out activities.

• Facilitate decentralized capabilities such as home health, ePRO, and DTP.

• Serve as a subject matter expert on Pfizer systems and processes.

• Develop efficiencies and best practices to enhance site performance and satisfaction of investigators/sites.

• Maintain effective communication with the Study Operations Manager and Global Study Manager.

• Provide local and cluster-level insights for country strategy, site recommendations, and territory development.

• Assist with local requirements for import/export processes concerning investigational medical products and ancillary supplies.

⛳️ Requirements

• A Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.

• A minimum of 7 years of experience is required.

• Must be able to manage travel requirements of up to 75% on a regular basis.

• Proficiency in English is mandatory; local language proficiency is preferred.

• Previous experience in site management, especially as a CRA/Site Monitor.

• Proven experience in start-up activities leading to site activation.

• Demonstrated experience in conducting studies and close-out activities.

• Comprehensive knowledge of quality and regulatory requirements in relevant countries.

• Familiarity with Good Clinical Practice/ICH Guidelines and other applicable regulatory mandates.

• Competent computer skills and a willingness to adopt new technologies.

• Strong communication, presentation, and interpersonal abilities.

• Skills in networking and relationship-building.

• Capability to manage cross-functional relationships effectively.

• Proficient in communicating with both internal and external stakeholders.

• Adaptability to evolving technologies and processes.

• Awareness of country-specific GCP requirements.

• Candidates must have authorization to work in the U.S. for any employer.

• Permanent work authorization in the United States is a prerequisite.

• U.S. work visa sponsorship is not available now or in the future.

🏝️ Benefits

• 401(k) plan with matching contributions from Pfizer.

• Additional retirement savings contributions from Pfizer.

• Paid vacation, holidays, and personal days.

• Paid caregiver/parental leave and medical leave.

• Coverage for medical, prescription drugs, dental, and vision.

• Relocation assistance may be provided based on business needs and/or eligibility.

• Opportunity to participate in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary.

• Eligibility to join Pfizer’s share-based long-term incentive program.