Site Care Partner - FSP (Senior/Lead CRA)

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

At least 8+ years of CRA experience is required.

Must have Oncology study experience.

Experience in other therapeutic area would be a plus.

Key Accountabilities :

Site start-up and activation
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Deploys client site strategies by qualifying and activating assigned sites

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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

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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

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Maintains a knowledge of assigned protocols

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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

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Ensures all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation

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Supports country specific ICF review and deployment up to Site Activation

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Ensures follow up activities’ completion post Site qualification visit and SIV to ensure site readiness for First Subject First Visit (FSFV)

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Partners with Clinical Research Associate (CRA) to ensure site monitoring readiness in anticipation of FSFV

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Responsible for relationship building and operational quality of the site

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Responsible for establishing and maintaining relationships with Site Organizations and Strategic Partners

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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.)

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Ensures the strategy and approach for Investigational Product (IP) and ancillary supplies for sites and country requirement throughout the lifecycle of the study

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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

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Partners with local Regulatory authorities and Study Start up teams to ensure timely completion on country / local registry up to Site Activation

Intelligence gathering
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Provides input into site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics

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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
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Reviews Site Reports and related issues

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Assures quality and consistency in the delivery of monitoring

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Supports the CRA to develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Study Management

Compliance with Parexel standards
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Complies with required training curriculum

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Completes timesheets accurately as required

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Submits expense reports as required

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Updates CV as required

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Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs, and other app