Site Care Partner I

0-2 years

Not Disclosed

India Remote

10 Feb. 10, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills:

Site Care Partner I
Location: India, Remote
Job ID: R0000029686
Category: Clinical Trials
Date Posted: 01/07/2025

Role Overview

The Site Care Partner I is responsible for the management and operational oversight of clinical trial sites. This role encompasses site start-up, activation, conduct, and close-out, ensuring compliance with study protocols and timelines. The Site Care Partner I works collaboratively with cross-functional teams and stakeholders to ensure smooth site operations, effective recruitment, and resolution of any site-related issues.

Key Responsibilities

Site Start-Up and Activation

Site Qualification and Activation: Deploy GSSO site strategies by qualifying and activating assigned sites.
Country & Site Selection Optimization: Support country and site selection activities, including the review and assessment of potential site lists.
Protocol Knowledge: Maintain a thorough understanding of assigned protocols to support site readiness.
Study Start-Up Activities: Coordinate and execute study start-up activities including PTA, coordination of site activation checklist items, and management of site activation issues.
Site Initiation: Ensure all site initiation activities are completed, including training, documentation collection (e.g., PSR, SART, ISF), and system updates.
ICD Review: Support country-specific ICD review and deployment when applicable.
Site Monitoring Readiness: Partner with site monitor to ensure readiness for the first subject visit.

Site Management and Support

Relationship Building: Develop and maintain relationships with investigator sites, providing operational oversight and support.
Escalation Management: Handle escalated site issues related to study delivery (e.g., vendor, site contracts, payment issues).
Recruitment and Enrollment Support: Ensure effective site recruitment and enrollment, tracking progress and addressing issues.
Communication: Maintain regular communication with sites to gather status updates and ensure alignment with study goals (e.g., recruitment, data entry timelines).
Site Readiness for FSFV: Ensure follow-up activities are completed post-PTA and SIV, ensuring readiness for FSFV.

Study Conduct and Close-Out

Operational Point of Contact: Serve as the operational point of contact for all site-level questions, liaising with internal teams for resolution.
Site Monitoring Reports: Review site monitoring reports and ensure adherence to study timelines.
ICD Submissions: Assist in the revision and submission of ICD documents and amendments.
System Management: Maintain system management at the site level, ensuring alignment across platforms (e.g., EDC, Site Profile, Shared Investigator Platform).
Site Performance Review: Review Site Management Organization Assessments on an annual basis, updating them when necessary.
Site Practice Management: Monitor site practices that differ from client practices, liaising with study management as needed.
Data Oversight: Ensure site deliverables align with study targets (e.g., data cuts, database locks).

Quality and Risk Management

Study Oversight: Follow the study oversight plan, proactively mitigating known and anticipated risks.
Decentralized Capabilities: Support the development and delivery of decentralized capabilities at investigator sites (e.g., home health, ePRO, DTP).
Monitoring Efficiencies: Drive efficiencies and best practices in monitoring and site performance throughout the study lifecycle.

Stakeholder Communication and Reporting

Client Reputation: Support the shaping of the local clinical development environment to enhance client reputation in scientific leadership.
Site Performance Intelligence: Provide input into site recommendations based on intimate knowledge of local/regional sites, processes, and performance metrics.
Local Regulatory Compliance: Support local requirements for importation/exportation processes of investigational products and ancillary supplies.

Qualifications

Training and Education

Education: Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience (minimum of 5 years’ experience).
Language Skills: Proficiency in the local language preferred; English required.

Prior Experience

Site Management Experience: Demonstrated experience in site management, with prior experience as a site monitor.
Start-Up and Close-Out Activities: Proven experience in site start-up, activation, conduct, and close-out activities.
Regulatory Knowledge: Demonstrated knowledge of quality and regulatory requirements in applicable countries.

Technical Competencies

GCP/ICH Guidelines Knowledge: Knowledge of Good Clinical Practice (GCP), ICH guidelines, and other applicable regulatory requirements.
Computer Skills: Good computer skills and the ability to embrace new technologies.
Communication and Presentation Skills: Strong communication, presentation, and interpersonal skills.
Travel: Ability to manage required travel (up to 75% regularly).
Networking Skills: Demonstrated networking and relationship-building skills.

Behavioral Competencies

Process Implementation: Ability to overcome barriers in implementing new processes and systems.
Relationship Building: Effective at building relationships with investigator site staff and other stakeholders.
Communication: Strong verbal and written communication skills in dealing with both internal and external stakeholders.

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