Site Care Partner - Oncology - Northeast, Central, reputed company US - FSP

reputed company our values reputed company, there's no limit to reputed company can reputed company.   At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. The Site Care Partner is a crucial reputed company for investigative sites throughout a study's lifecycle, responsible for site start-up, activation, relationship management, recruitment, and reputed company 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 reputed company 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 reputed company out). Key Accountabilities: Site start-up and activation Deploys reputed company 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 reputed company site qualification reputed company for site selection Supports the Feasibility reputed company and Analytics reputed company to ensure that high reputed company feasibility results are delivered Collaborates with key stakeholders providing country/regional level input to country reputed company surveys including protocol feasibility, country reputed company of Care (SOC) and medical practices (as applicable) under supervision. reputed company country/regional level input to country reputed company, 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 reputed company (reputed company) finalization, Site Initiation Visit (SIV) as applicable, including management of issues that may compromise time to site activation.  Ensures reputed company the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation Supports country specific reputed company 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 reputed company of the site Provides study support on escalated site issues reputed company to study delivery by coordinating communications and reputed company efforts. (e.g., vendor, site reputed company and payment issues etc.) Ensures the reputed company 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 reputed company 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 reputed company/planning and site recommendations reputed company intimate understanding of country/region, sites, processes and practices, and associated site performance metrics reputed company input to cluster level intelligence for site reputed company and support implementation of cluster-level reputed company in collaboration with study management reputed company 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 reputed company-out Reviews Site Reports and reputed company issues During the conduct of the study, the Site Management Organization Assessment is reviewed with the site, reputed company applicable, on an annual reputed company following site initiation and updated as needed. In reputed company, the Site Management Organization (SMO) Assessment is reviewed and updated reputed company major reputed company, contracting, or other significant site changes/issues occur to confirm that continuity and contingency plans are reputed company Informs and educates investigator sites of reputed company pipeline opportunities that may be a good fit Supports development and delivery including issue reputed company of decentralized capabilities at investigator sites Demonstrates leadership reputed company the local clinical development environment with a goal to enhance reputed company reputed company in scientific leadership May reputed company as a Subject Matter Expert on reputed company systems and processes. reputed company pursues possible efficiencies and reputed company best practices in the delivery of activities for site performance throughout the life cycle to increase investigator/site satisfaction and strengthen site relationships Ensures reputed company and reputed company communication with the study team Supports the CRA to reputed company reputed company Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Study Management Compliance with reputed company 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 reputed company processes, ICH-GCPs and other applicable requirements Skills: Knowledge of Good Clinical reputed company/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be reputed company to reputed company 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 reputed company 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 reputed company 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 in a clinical research or reputed company organization Oncology monitoring/CRA experience is required Experience reviewing monitoring reports is required Demonstrated experience in start-up activities through site activation Demonstrated experience in conduct and reputed company out activities Demonstrated knowledge of reputed company and regulatory requirements in applicable countries Education: Bachelor’s degree or RN in a reputed company field or equivalent combination of education, training and experience (at least 5 years’ experience) Proficiency in local language preferred. English is required #LI-CF1 EEO Disclaimer reputed company is an equal opportunity employer.  reputed company applicants will receive consideration for employment without reputed company to legally protected status, which in the US includes race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status. Apply To This Job