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As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity. Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally. 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.
Job Responsibility:
Site start-up and activation
Deploys client site strategies by qualifying and activating assigned sites
Supports processes to optimize country & site selection activities
Collaborates with key stakeholders providing country/regional level input to country outreach surveys
Maintains a knowledge of assigned protocols
Conducts study start-up activities at the site level
Ensures all the site initiation activity including training per site activation checklist
Supports country specific ICF review and deployment up to Site Activation
Ensures follow up activities’ completion post Site qualification visit and SIV
Partners with Clinical Research Associate (CRA) to ensure site monitoring readiness
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
Ensures the strategy and approach for Investigational Product (IP) and ancillary supplies for sites and country requirement
Accountable for effective site recruitment planning and delivery
Partners with local Regulatory authorities and Study Start up teams to ensure timely completion on country / local registry
Intelligence gathering
Provides input into site recommendations via intimate understanding of country/region, sites, processes and practices
Provides support to study management to define local requirements for the importation/exportation processes
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
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
Requirements:
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Good computer skills and ability 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 with internal & external stakeholders
Ability to adapt to changing technologies and processes
Knowledge of country requirements for GCP
Effectively overcoming barriers during implementation of new processes and systems
Identifies and builds effective relationships with investigator site staff and other stakeholders
Effective verbal and written communication skills
Able to manage escalated site issues
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)