Study start-Up and activation:

• Deploys Global Site and Study Operations (GSSO) site strategies by qualifying and activating assigned site 

• Supports processes to optimize country and site selection activities including review and assessment of the draft potential site list and provide Pre-Trial Assessment (PTA) 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 PTA, coordination of site activation checklist items, Informed Consent Document (ICD) 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 (e.g. PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF etc.)  

• Supports country specific ICD review and deployment up to Site Activation   

• Ensures follow up activities’ completion post PTA 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 Authority (RA)/ Clinical Trial Regulatory Operations (CTRO) / Site Activation Partner (SAP) 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 the Study Operations Manager/Global Study Manager to define local requirements for the importation/exportation processes of the investigational medical product and ancillary suppl 

Study conduct and closeout:

• 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 and Technical Competencies: 

• 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  

Behavioral Competencies: 

• 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  

• Demonstrated experience in start-up activities through to 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