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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. The Site Care Partner may be expected to support Country Specific Activities that are required to ensure end-to-end clinical trial implementation (start up to close out).
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
- Supports the Feasibility Strategy and Analytics Lead to ensure that high quality feasibility results are delivered
- 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.
- Provide country/regional level input to country strategy, feasibility and protocol design in collaboration with relevant Medical Affairs colleagues, and with input from external clinical experts as required.
- 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
- 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
- Responsible for establishing and maintaining relationships with Site Organizations and Strategic Partners
Intelligence gathering
- Provides input into country strategy/planning and site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics
- Provide input to cluster level intelligence for site strategy and support implementation of cluster-level strategy in collaboration with study management
- Provide regional exploration/territory development growing adjacent opportunities where possible
- 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
- During the conduct of the study, the Site Management Organization Assessment is reviewed with the site, when applicable, on an annual basis following site initiation and updated as needed. In addition, the Site Management Organization (SMO) Assessment is reviewed and updated when major staffing, contracting, or other significant site changes/issues occur to confirm that continuity and contingency plans are current
- Informs and educates investigator sites of client pipeline opportunities that may be a good fit
- Supports development and delivery including issue resolution of decentralized capabilities at investigator sites
- Demonstrates leadership within the local clinical development environment with a goal to enhance client reputation in scientific leadership
- May act as a Subject Matter Expert on client systems and processes.
- Actively pursues possible efficiencies and develop best practices in the delivery of activities for site performance throughout the life cycle to increase investigator/site satisfaction and strengthen site relationships
- Ensures clear and open communication with the study team
- 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:
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent 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
- Effective in managing cross functional relationships
Knowledge and Experience:
- Demonstrated experience in site management with 5 years prior experience as a CRA
- Oncology monitoring/CRA experience is required
- 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 (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.
Originally posted on Himalayas