Site Care Partner

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Act as the primary point of contact for clients at investigative sites throughout the duration of the study

• Oversee site start-up processes until activation

• Develop and maintain relationships with investigator sites, offering assistance from site recommendations to study completion

• Aid in the selection of countries and sites by providing local insights and collaborating with involved parties

• Perform site-level start-up tasks, which include PTA, coordinating activation checklists, finalizing ICDs, and conducting SIVs as necessary

• Organize site initiation training and gather or finalize required activation documents and systems

• Ensure readiness of sites for the first subject's initial visit in collaboration with site monitors

• Manage the resolution of escalated issues at the site level, covering vendor, contracts, and payment concerns

• Support strategies for investigational products and ancillary supplies throughout the study's duration

• Plan and assist in site recruitment, enrollment, and address investigator concerns regarding recruitment

• Maintain consistent communication with investigator sites while tracking recruitment, data entry, performance metrics, and study feedback

• Facilitate the completion of country or local registries in conjunction with local RA, CTRO, and SAP stakeholders

• Serve as the operational point of contact for inquiries at the site level and escalate issues as necessary

• Review monitoring reports from sites and assist with revisions and submissions of ICD documents

• Maintain site-level systems and ensure alignment across EDC, Shared Investigator Platform, Site Profile, and other relevant systems

• Review and update Site Management Organization Assessments and continuity or contingency strategies

• Manage site practices that deviate from client protocols and communicate with study management and process owners

• Oversee site deliverables such as data cuts, interim analyses, database locks, and investigator signatures

• Adhere to study oversight plans and implement risk mitigation strategies

• Facilitate decentralized capabilities like home health, ePRO, and DTP

• Ensure the quality and consistency of monitoring delivery while promoting efficiencies and best practices

• Foster positive relationships with investigators and address any training or compliance issues

• Provide local insights and feedback on site recommendations and performance metrics

• Assist with local requirements for the import and export of investigational products and ancillary supplies

⛳️ Requirements

• Strong communication skills for effective interaction with internal and external stakeholders

• Ability to adapt to evolving technologies and processes

• Proven networking and relationship-building capabilities

• Experience in managing cross-functional relationships

• Demonstrated site management experience with prior roles as a site monitor

• Background in full lifecycle activities from site start-up and activation through to closeout

• Knowledge of quality and regulatory standards relevant to the country of employment

• Familiarity with Good Clinical Practice (GCP), International Council for Harmonization (ICH) Guidelines, and other pertinent regulatory standards

• Willingness to travel up to 50% regularly

• Proficiency in the local language

• Proficient in English

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

• A minimum of 5 years of experience is estimated for the equivalent combination pathway

🏝️ Benefits

• Opportunity for remote work

• Full-time employment