Site Care Partner/Lead CRA - FSP

Parexel•Southport, NC

25d

About The Position

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. 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.

Requirements

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
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
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

Responsibilities

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 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
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
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