Site Care Partner – Min 6+ years experience in Oncology

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Conduct site qualification, initiation, interim monitoring, site management, and close-out visits either on-site or remotely.

• Assess the performance of sites and site staff, providing tailored recommendations for site-specific improvements.

• Communicate critical issues to the project team and devise appropriate action plans.

• Ensure informed consent processes, subject/patient confidentiality, safety, and the integrity of clinical data are upheld.

• Perform source document reviews and confirm the accuracy of clinical data entered in CRFs.

• Address queries both remotely and on-site within established timelines.

• Utilize hardware and software for reviewing and capturing clinical study data; ensure compliance with EDC standards.

• Oversee investigational product inventory, including reconciliation, storage, security, dispensing, and adherence to administration protocols.

• Examine Investigator Site Files and ensure they are reconciled with Trial Master Files.

• Document activities through confirmation letters, follow-ups, trip reports, communication logs, and other relevant project documents.

• Assist in strategies for subject/patient recruitment, retention, and awareness.

• Monitor observations, ongoing statuses, and ensure action items are resolved.

• Manage site-level activities and communications to achieve project objectives, deliverables, and timelines.

• Serve as a liaison with study site personnel, ensuring that assigned sites and project-specific team members are adequately trained and compliant.

• Participate in investigator, sponsor, clinical monitoring, and training meetings.

• Facilitate audit readiness, preparation for audits, and follow-up actions.

• Provide guidance, training, and mentorship to junior CRAs; conduct training and sign-off visits.

• For RWLP: support sites throughout the study lifecycle, conduct chart abstraction and data collection, collaborate with sponsors and affiliates, identify potential sites, enhance processes, develop informed consent forms, assist with regulatory activities, and participate in bid defense, RFP, budgeting, CRF design, and edit check development.

⛳️ Requirements

• A minimum of 6+ years of prior monitoring experience is required.

• Experience in oncology monitoring is highly desirable.

• A Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Proficient computer skills and a willingness to adopt new technologies.

• Exceptional communication, presentation, and interpersonal abilities.

• Moderate critical thinking skills are necessary.

• Ability to manage travel requirements of up to 75% regularly.

• Comprehensive understanding of ICH/GCP Guidelines, pertinent regulations, and company SOPs/processes.

• Competence in performing site qualification, initiation, monitoring, management, and close-out activities either on-site or remotely.

• Experience working with clinical data, source documents, medical records, CRFs, EDC systems, ISF, and TMF.

• Capability to manage site-level activities, communications, project objectives, deliverables, and timelines.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• A comprehensive total rewards program.

• Emphasis on a Total Self culture.

• A workplace culture focused on diversity, equity, and inclusion.