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Parexel

Site Care Partner/Lead CRA - Northeast - FSP

Career Insights for Clinical Research Associate

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What they do

A Clinical Research Associate is responsible for running clinical trials, usually for an organization undertaking pharmacological drug testing. Will ensure that trials adhere to good clinical practice guidelines for monitoring clinical trials.

$105,028 / year median in Kansas

+1% projected growth

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Job Description

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.
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 + 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 + 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 + Responsible for establishing and maintaining relationships with Site Organizations and Strategic Partners + 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 To view full details and how to apply, please login or create a Job Seeker account