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Site Care Partner I

5+ years
Not Disclosed
10 Feb. 18, 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
Location: India (Remote)
Job ID: R0000029686
Category: Clinical Trials
Date Posted: 01/07/2025


Company Overview:

At our company, we strive to deliver the highest standards in clinical trials and research. Our team of clinical experts ensures the seamless execution of clinical studies, from startup to close-out, while maintaining strong site relationships and compliance with regulatory standards. We're looking for a Site Care Partner I to join our team and manage site-level activities for multiple studies.


Job Overview:

The Site Care Partner I is responsible for overseeing the site start-up and activation processes, ensuring smooth site initiation, monitoring, and delivery of clinical trials. This role will require collaborating with internal and external stakeholders, managing site relationships, and ensuring that site-level activities align with study timelines, recruitment targets, and regulatory standards.


Key Responsibilities:

Site Start-Up and Activation:

  • Deploy GSSO site strategies by qualifying and activating assigned sites.

  • Support site selection activities, including reviewing and assessing potential sites, and providing input on protocol feasibility.

  • Maintain thorough knowledge of assigned protocols.

  • Conduct study start-up activities, including site activation checklist items, finalizing Informed Consent Documents (ICD), and ensuring training is completed for site initiation.

  • Coordinate with site monitors to ensure readiness for first subject first visit (FSFV).

Study Conduct and Close-Out:

  • Act as the operational point of contact for site-level questions, liaising with internal teams to resolve any issues or concerns.

  • Monitor and manage site deliverables, including data entry timelines and recruitment targets.

  • Ensure effective communication with investigator sites to gather status updates, performance metrics, and feedback.

  • Oversee the submission and revision of site documentation, including Informed Consent Documents (ICD) and amendments.

  • Ensure compliance with regulatory requirements and client procedures.

  • Provide support for decentralized capabilities at investigator sites (e.g., home health, ePRO, DTP).

Relationship and Site Management:

  • Build and maintain strong relationships with investigator sites.

  • Act as a key point of contact to resolve issues and ensure study goals are met.

  • Ensure timely completion of site-related activities to support study progress.

  • Ensure that site strategies and the approach for investigational product (IP) and ancillary supplies align with local and global requirements throughout the lifecycle of the study.

Risk Management and Efficiency:

  • Proactively manage potential risks, including recruitment and operational issues, and put mitigation strategies in place.

  • Drive best practices and efficiencies in site monitoring and management.

  • Identify potential areas for process improvement to enhance investigator/site satisfaction and strengthen site relationships.


Qualifications:

Education:

  • Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience (approximately 5+ years of experience).

Prior Experience:

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

  • Experience in start-up, activation, conduct, and close-out activities of clinical trials.

  • Strong knowledge of quality and regulatory requirements in applicable countries.

Technical Competencies:

  • Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other regulatory requirements.

  • Proficiency in using clinical trial management systems and other relevant technologies.

  • Strong communication, presentation, and interpersonal skills.

  • Ability to travel up to 75% as required for site management activities.

Behavioral Competencies:

  • Excellent relationship-building and networking skills with investigator sites and stakeholders.

  • Ability to adapt to new technologies and processes.

  • Strong verbal and written communication skills with the ability to relate to colleagues and associates effectively.

  • Ability to manage cross-functional relationships and overcome barriers during the implementation of new processes and systems.