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 sitesSupports processes to optimize country & site selection activities including review and assessment of the draft potential site list and provide site qualification output for site selectionCollaborates 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 supervisionMaintains a knowledge of assigned protocolsConducts 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 activationEnsures all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activationSupports country specific ICF review and deployment up to Site ActivationEnsures 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 FSFVResponsible for relationship building and operational quality of the siteResponsible for establishing and maintaining relationships with Site Organizations and Strategic PartnersProvides 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 studyAccountable 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 conductPartners 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 metricsProvides 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 issuesAssures quality and consistency in the delivery of monitoringSupports 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 curriculumCompletes timesheets accurately as requiredSubmits expense reports as requiredUpdates CV as requiredMaintains 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 requirementsMust demonstrate good computer skills and be able to embrace new technologiesGood communication, presentation, and interpersonal skillsAbility to manage required travelDemonstrated networking and relationship building skillsDemonstrated ability to manage cross functional relationshipsAbility to communicate effectively and appropriately with internal & external stakeholdersAbility to adapt to changing technologies and processesKnowledge of country requirements for GCP that may be different to those of client proceduresEffectively overcoming barriers encountered during the implementation of new processes and systemsIdentifies and builds effective relationships with investigator site staff and other stakeholdersEffective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organizationAble 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 OncologyDemonstrated experience in start-up activities through site activationDemonstrated experience in conduct and close out activitiesDemonstrated 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

#LI-LO1

#LI-REMOTE

EEO Disclaimer

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