Site Care Partner - FSP

The Site Care Partner I (SCP I) is the “face of the client “ and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and client’s reputation is upheld throughout study lifecycle.  The Site Care Partner is the main client point of contact for investigative sites ; accountable for site start up activities through activation; accountable for building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies; accountable for site-level recruitment and operational success, and accountable for safeguarding the quality and patient safety at the investigator site. 

Key Accountabilities:

• Provides input into site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics

• Provides support to the Study Operations Manager/Global Study Manager to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies

• Deploys Global Site and Study Operations (GSSO) 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 & provide Pre-Trial Assessment  (PTA) output for site selection.

• Collaborates with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country Standard of Care and medical practices (as applicable) under supervision

• Maintains a thorough knowledge of assigned protocols

• Conducts study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, Informed Consent Document (ICD) 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

• Supports country specific ICD review and deployment when applicable

• Ensures follow up activities completed post PTA and SIV to ensure site readiness for First Subject First Visit (FSFV) 

• Partners with site monitor to ensure site monitoring readiness in anticipation of FSFV

• Responsible for relationship building and operational oversight of the site

• Provides study support for 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/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

• Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators

• Maintains regular communications with investigator sites to gather status updates and drive delivery to study goals (e.g. recruitment, data entry timelines etc.)

• Partners with local Regulatory Authority (RA)/ Clinical Trial Regulatory Operations (CTRO) / Site Activation Partner (SAP) to ensure timely completion on country / local registry when applicable

• Acts as operational point of contact for all site-level questions, liaising with and escalating to appropriate teams to respond and resolve questions

• Reviews site monitoring reports

• Supports the site with revision and submission of ICD documents (and amendments)

• Works with other roles to maintain system management (e.g., Electronic Data Capture, Shared Investigator Platform, Site Profile and other systems as applicable) at site level ensuring alignment across platforms

• 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 under client/ Senior SCP supervision. 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

• Reviews and manages site practices that differ from client practices and liaises with study management and Business Process Owners as needed

• Maintains regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study level feedback

• Oversight and management of site deliverables to study targets, i.e. data cuts/sweeps, interim analyses, database locks, helping to oversee data is up to date and any other site-facing deliverables, i.e. investigator signatures

• Follows the study oversight plan and proactively puts in place mitigations for known/anticipated risks

• Supports development and delivery, including issue resolution, of decentralized capabilities at investigator sites

• Assures quality and consistency in the delivery of monitoring

• Drives monitoring efficiencies and best practices for study/region/program

• Supports shaping 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 Study Operations Manager

• Supports the site monitor to develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Country Trials Manager and Study Management

• Coordinates with other roles and functions that will interface with study sites (e.g., Study Monitor, Investigator Contracts Lead, Site Activation Partner, Clinician, etc.) thereby, optimizing communications and enhancing overall visibility into and confidence of quality of site level activities

• Site oversight utilizing and interpreting data from analytic tools, in conjunction with country intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks

Skills:

• Ability to communicate effectively and appropriately with internal & external stakeholders

• Ability to adapt to changing technologies and processes

• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization

• Demonstrated networking and relationship building skills

• Demonstrated ability to manage cross functional relationships

• Effectively overcoming barriers encountered during the implementation of new processes and systems

• Identifies and builds effective relationships with investigator site staff and other stakeholders

• Proficiency in local language preferred

• English and local language are required

Knowledge and Experience:

• Demonstrated experience in site management with prior experience as a site monitor

• Demonstrated experience in start up activities through to site activation

• Demonstrated experience in conduct and close out activities

• Demonstrated knowledge of quality and regulatory requirements in applicable countries

• Knowledge of Good Clinical Practice (GCP)/International Council for Harmonization (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 of up to 75% on a regular basis

• Knowledge of country requirements for GCP that may be different to those of client  procedures

Education:

• Bachelor’s degree or Registered Nurse in a related field or equivalent combination of education, training and experience (estimate at least 5 years experience)