Site Care Partner - Fsp

5+ years

Not Disclosed

Bangalore

10 Jan. 21, 2025

Job Description

Job Type: Remote Education: B.Sc, M.Sc, B.Pharma, M.Pharma, Life Science Graduates 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

Site Care Partner - FSP
Location: India-Bengaluru-Remote
Posted: 4 Days Ago
Job Requisition ID: R0000030593

Role Summary

The Site Care Partner serves as the main point of contact for investigative sites throughout the study lifecycle. This role is accountable for site start-up activities, activation, and operational success, as well as ensuring quality and patient safety at the investigator site. The Site Care Partner builds and maintains relationships with investigator sites, supports recruitment, and resolves operational issues. They also collaborate with other study team members to enhance site visibility and maintain quality standards throughout the study.

The Site Care Partner will support country and site selection activities, proactively collaborating with key stakeholders to contribute insights on protocol feasibility and medical practices. Additionally, this role involves managing site oversight using analytics to identify risks and develop mitigation plans. As the "face of the client," the Site Care Partner ensures that site-related issues are resolved promptly and that the client's reputation is upheld throughout the study lifecycle.

Key Responsibilities

1. Site Start-Up and Activation:

Deploy GSSO site strategies and qualify/activate assigned sites.
Support country and site selection activities, including reviewing potential sites and providing input for protocol feasibility and medical practices.
Conduct study start-up activities at the site level, including PTA, site activation checklist coordination, and SIV.
Ensure site initiation activities (e.g., training, document collection) are completed for site activation.
Partner with site monitors to ensure site readiness for the first subject visit.

2. Relationship Building and Operational Oversight:

Provide support for escalated site issues, including vendor, contract, and payment concerns.
Support IP and ancillary supply strategies for sites throughout the study lifecycle.
Ensure effective site recruitment planning and address any recruitment issues.
Maintain regular communication with sites to monitor progress and resolve issues related to recruitment and data entry timelines.

3. Study Conduct and Close-Out:

Act as the operational point of contact for site-level questions and escalate issues as needed.
Review Site Monitoring Reports and support the revision and submission of ICD documents.
Ensure alignment of system management across platforms (e.g., EDC, Shared Investigator Platform).
Oversee site deliverables, including data entry, interim analyses, and database locks.
Develop mitigation plans for anticipated risks and follow the study oversight plan.

4. Site Performance and Efficiency:

Actively pursue efficiencies and best practices to improve site performance and strengthen site relationships.
Support decentralized capabilities at investigator sites, such as home health and ePRO.
Foster positive relationships between site monitors and investigators.
Provide input into site recommendations based on local knowledge of country/region-specific practices.

5. Communication and Collaboration:

Communicate effectively with internal and external stakeholders to resolve issues and ensure smooth study conduct.
Collaborate with the Study Operations Manager to ensure compliance with country-specific requirements and regulatory guidelines.
Participate in ongoing site performance reviews and make adjustments as needed to meet study goals.

Qualifications

Education:

Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience (at least 5 years of experience).

Prior Experience:

Experience in site management, including site monitoring, start-up, conduct, and close-out activities.
Knowledge of quality and regulatory requirements in applicable countries.

Technical Skills:

Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other applicable regulatory requirements.
Proficiency with computer systems and willingness to adapt to new technologies.
Strong communication, presentation, and interpersonal skills.
Ability to manage up to 75% travel regularly.
Proven networking and relationship-building abilities.

Behavioral Competencies:

Ability to overcome barriers during the implementation of new processes and systems.
Build and maintain effective relationships with site staff and other stakeholders.
Excellent verbal and written communication skills.
Ability to adapt to changing technologies and processes.

Travel Requirements

Up to 75% travel may be required on a regular basis.

Parexel is committed to improving global health by advancing therapies for patients. If you are passionate about clinical trials, regulatory processes, and making a meaningful impact, this role offers an opportunity to contribute to something that truly matters.

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Site Care Partner - Fsp

Job Description

Role Summary

Key Responsibilities

Qualifications

Travel Requirements

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