Site Care Partner I

0-2 years

Not Disclosed

India Remote

10 Feb. 7, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Site Care Partner I

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

Key Responsibilities:

1. Site Start-Up and Activation:

Site Qualification and Activation: Deploy GSSO site strategies by qualifying and activating assigned sites.
Site Selection Activities: Support processes for country & site selection, including reviewing and assessing the draft site list and providing PTA output for site selection.
Feasibility and Outreach: Collaborate with stakeholders to provide country/regional-level input for protocol feasibility, country SOC, and medical practices.
Study Knowledge: Maintain thorough knowledge of assigned protocols.
Study Start-Up: Coordinate study start-up activities at the site level, including PTA, site activation checklist items, ICD finalization, and SIV management.

2. Site Initiation and Documentation:

Site Training & Documentation: Ensure all site initiation activities are completed, including training, documentation, and systems needed for site activation (e.g., PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF, etc.).
ICD Review and Deployment: Support country-specific ICD review and deployment when applicable.
Site Monitoring Readiness: Ensure follow-up activities are completed post-PTA and SIV to ensure site readiness for FSFV.

3. Site Management and Support:

Relationship Building: Foster strong relationships and operational oversight with investigator sites.
Escalated Issues: Provide support for escalated site issues related to study delivery (e.g., vendor, site contracts, payment issues).
IP and Ancillary Supplies: Oversee IP and ancillary supplies strategy for sites and ensure compliance with country requirements throughout the study lifecycle.
Enrollment Support: Be accountable for effective site recruitment planning, delivery, and ensuring progress by addressing recruitment issues from investigators.

4. Communication and Collaboration:

Status Updates: Maintain regular communications with investigator sites to gather status updates and drive study goal delivery (e.g., recruitment, data entry timelines).
Local Collaboration: Partner with local RA/CTRO/SAP to ensure timely completion of country/local registry when applicable.

5. Study Conduct and Close-Out:

Operational Point of Contact: Serve as the operational point of contact for all site-level questions and escalate to appropriate teams when necessary.
Site Monitoring Reports: Review site monitoring reports and assist with revisions and submissions of ICD documents (and amendments).
System Management: Manage system platforms (e.g., EDC, Shared Investigator Platform, Site Profile) to ensure alignment across platforms.
SMO Assessment: Review and update the SMO Assessment annually or when significant site changes occur.

6. Site Performance and Compliance:

Oversight of Site Deliverables: Ensure site deliverables are met, including data cuts, interim analyses, database locks, and investigator signatures.
Risk Mitigation: Follow the study oversight plan and proactively implement mitigations for known/anticipated risks.
Decentralized Capabilities: Support the development and delivery of decentralized capabilities at investigator sites (e.g., home health, ePRO, DTP).

7. Monitoring and Best Practices:

Monitoring Efficiency: Drive monitoring efficiencies and best practices for the study, region, and program.
Client Reputation: Support shaping the local clinical development environment to enhance Client's scientific leadership reputation.
Site Performance Improvements: Actively pursue possible efficiencies and develop best practices to improve site performance throughout the study lifecycle.

8. Investigator Relationship Management:

Investigator Relationship Development: Build and maintain positive investigator relationships and escalate any training or compliance concerns with the Country Trials Manager and Study Management.
Site Intelligence: Proactively provide local intelligence based on in-depth understanding of country/region, sites, processes, and performance metrics.

9. Local Requirements and Import/Export Support:

Site Recommendations: Provide input into site recommendations based on local knowledge and site performance metrics.
Import/Export Support: Support the Study Operations Manager/Global Study Manager in defining local requirements for the importation/exportation of investigational medical products and ancillary supplies.

Qualifications:

Education:

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

Prior Experience:

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

Technical Competencies:

Clinical Guidelines: Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other applicable regulatory requirements.
Computer Skills: Strong computer skills and the ability to embrace new technologies.
Communication Skills: Excellent communication, presentation, and interpersonal skills.
Travel Requirement: Ability to manage required travel of up to 75% on a regular basis.
Networking & Relationship Building: Demonstrated ability to manage cross-functional relationships and build effective relationships with investigator site staff.

Behavioral Competencies:

Problem-Solving: Ability to overcome barriers encountered during the implementation of new processes and systems.
Effective Communication: Ability to communicate effectively with colleagues, associates, and external stakeholders.
Adaptability: Ability to adapt to changing technologies and processes.
Relationship Building: Build and maintain effective relationships with investigator site staff and other stakeholders.

Additional Information:

Remote Role: This position is remote, allowing flexibility in work location.

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