Site Care Partner - All US Locations - FSP

Parexel; Raleigh (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

Parexel is seeking a Site Care Partner to liaise with investigative sites throughout study lifecycles, handling start-up, activation, recruitment, and quality assurance. You will coordinate with CRA teams, ensure site readiness, and manage issues to protect patient safety while maintaining Parexel standards.

Responsibilities include site qualification, activation planning, monitoring readiness, and collaboration with regulatory authorities to ensure timely site activation and compliant study

Qualifications

• Knowledge of GCP/ICH guidelines and regulatory requirements.
• Strong communication and interpersonal skills.
• Ability to travel as needed to sites and regions.
• Experience building relationships with investigators and sites.
• Ability to manage cross-functional relationships and escalations.

Responsibilities

• Lead site start-up/activation and manage relationships with sites and vendors.
• Coordinate site qualification, ICF finalization, SIV, and activation tasks.
• Support site recruitment planning and enrollment delivery with CRA collaboration.
• Provide local country input for feasibility and SOC practices.
• Monitor site performance, resolve issues, and ensure patient safety.
• Ensure Parexel standards, training, timesheets, and expense reporting.

Skills

GCP Knowledge

Communication skills

Interpersonal skills

Travel willingness

Cross-functional collaboration

Relationship building

Data analysis

Education

Bachelor's degree or RN

Job description

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 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 elevate 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
• 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.