Site Care Partner Ii

6 months ago

Mumbai Maharashtra, India Parexel Full time

**Job **Purpose**:
The Site Care Partner II (SCP II) 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 SCP II 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. The SCP II contributes to country and site selection activities by proactively collaborating with key stakeholders and providing local intelligence to country outreach surveys, investigator strategies and client pipeline opportunities under supervision. The SCP II may be expected to support country specific activities that are required to assure end to end clinical trial implementation (start up to close out).

Key Accountabilities:
**Accountability**

**Supporting **Activities**

may include but not limited to the following

**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
- Provides input to cluster level intelligence for site strategy and support implementation of cluster-level strategy in collaboration with the Study Operations Manager (SOM)/Global Study Manager (Global SM)
- Provides regional exploration/territory development growing adjacent opportunities where possible.
- Provides support to the SOM/Global SM to define local requirements for the importation/exportation processes of the investigational medical

product and ancillary supplies

**Study Start-Up and **Activation**
- 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.
- 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 and medical practices (as applicable).
- Provides 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 thorough knowledge of assigned protocols
- Conduct 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 for site activation
- 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
- Responsible for relationship building and operational oversight 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/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

**Study Conduct and **Closeout**
- Acts as operational point of contact for all site 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, maintain system management (e.g., Electronic Data Capture (EDC), Shared Investigator Platform, Site Profile and other systems

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