Site Care Partner; Lead Clinical Research Associate - Oncology - FSP

Job Description

Qualifications

Benefits

Responsibilities

• •The Site Care Partner is a crucial liaison for investigative sites throughout a study's lifecycle, responsible for site start-up, activation, relationship management, recruitment, and quality assurance
• •This role also contributes to site selection, provides local intelligence, ensures site support, resolves issues, and collaborates with various functions to optimize communication, maintain site quality and patient safety utilizing data analytics to identify and mitigate risks
• •The Site Care Partner may be expected to support Country Specific Activities that are required to ensure end-to-end clinical trial implementation (start up to close out)
• •Key Accountabilities Site start-up and activation
• •Deploys client site strategies by qualifying and activating assigned sites
• •Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list and provide site qualification output for site selection
• •Supports the Feasibility Strategy and Analytics Lead to ensure that high quality feasibility results are delivered
• •Collaborates with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country Standard of Care (SOC) and medical practices (as applicable) under supervision
• •Provide country/regional level input to country strategy, feasibility and protocol design in collaboration with relevant Medical Affairs colleagues, and with input from external clinical experts as required
• •Maintains a knowledge of assigned protocols
• •Conducts study start-up activities at the site level including but not limited to Site Qualification, coordination of site activation checklist items, Informed Consent Form (ICF) finalization, Site Initiation Visit (SIV) as applicable, including management of issues that may compromise time to site activation
• •Ensures all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation
• •Supports country specific ICF review and deployment up to Site Activation
• •Ensures follow up activities’ completion post Site Qualification visit and SIV to ensure site readiness for First Subject First Visit (FSFV)
• •Partners with Clinical Research Associate (CRA) to ensure site monitoring readiness in anticipation of FSFV
• •Responsible for relationship building and operational quality of the site
• •Provides study support on escalated site issues related to study delivery by coordinating communications and resolution efforts
• •(e.g., vendor, site contracts and payment issues etc.)
• •Ensures the strategy and approach for Investigational Product (IP) and ancillary supplies for sites and country requirement throughout the lifecycle of the study
• •Accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets;
• •Jointly responsible with CRA for enrollment delivery during study conduct
• •Partners with local Regulatory authorities and Study Start up teams to ensure timely completion on country / local registry up to Site Activation
• •Responsible for establishing and maintaining relationships with Site Organizations and Strategic Partners
• •Provides input into country strategy/planning and site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics
• •Provide input to cluster level intelligence for site strategy and support implementation of cluster-level strategy in collaboration with study management
• •Provide regional exploration/territory development growing adjacent opportunities where possible
• •Provides support to study management to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies
• •Study conduct and close-out
• •Reviews Site Reports and related issues
• •During the conduct of the study, the Site Management Organization Assessment is reviewed with the site, when applicable, on an annual basis following site initiation and updated as needed