Site Care Partner / Lead CRA - FSP

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

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 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

Intelligence gathering

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

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

Assures quality and consistency in the delivery of monitoring

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

Complies with required training curriculum

Completes timesheets accurately as required

Submits expense reports as required

Updates CV as required

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

Skills

Knowledge of Good Clinical Practice / ICH Guidelines and other applicable regulatory requirements

Must demonstrate good computer skills and be able to embrace new technologies

Good communication, presentation, and interpersonal skills

Ability to manage required travel

Demonstrated networking and relationship building skills

Demonstrated ability to manage cross functional relationships

Ability to communicate effectively and appropriately with internal & external stakeholders

Ability to adapt to changing technologies and processes

Knowledge of country requirements for GCP that may be different to those of client procedures

Effectively overcoming barriers encountered during the implementation of new processes and systems

Identifies and builds effective relationships with investigator site staff and other stakeholders

Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization

Able to manage issues that are escalated by site staff in a way that meets the needs of both the client and the site staff

Knowledge and Experience

Demonstrated experience in site management with prior experience as a CRA in Oncology

Demonstrated experience in start-up activities through site activation

Demonstrated experience in conduct and close out activities

Demonstrated knowledge of quality and regulatory requirements in applicable countries

Education

Bachelor's degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 5 years' experience)

Proficiency in local language preferred. English is required

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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