Associate Site Manager – Oncology

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🕒 vor 1 Tag

🦌 Connecticut, Maine, +9 weitere Bundesländer – Remote

🦌 Connecticut – Remote 🦞 Maine – Remote 🗻 New Hampshire – Remote 🏖️ New Jersey – Remote 🗽 New York – Remote 🏈 Ohio – Remote 🍂 Massachusetts – Remote 🚗 Michigan – Remote 🔔 Pennsylvania – Remote ⚓ Rhode Island – Remote 🍁 Vermont – Remote

💵 $76.000 - $121.900 / Jahr

⏰ Vollzeit

🟢 Junior

🟡 Mittelstufe

👔 Manager

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Johnson & Johnson

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10.000+ Mitarbeiter

🏥 Gesundheitswesen

💊 Pharmazie

🧬 Biotechnologie

Healthcare • Pharmaceuticals • Biotechnology

<Johnson & Johnson> ist ein globales Gesundheitsunternehmen, das sich mit der Erforschung, Entwicklung, Herstellung und Vermarktung von Pharmazeutika, Medizinprodukten und Produkten für die Gesundheitspflege beschäftigt. Das Unternehmen konzentriert sich auf innovative Arzneimittel und Therapien in den Bereichen Onkologie, Immunologie, Neurowissenschaften und Kardiopulmonar. Zudem entwickelt Johnson & Johnson Medizintechniklösungen in den Bereichen Herz-Kreislauf, Orthopädie, Chirurgie und Sehhilfen. Johnson & Johnson engagiert sich zudem in der Gesundheits- und Wellness-Bildung, der großflächigen Fertigung, Investorenaktivitäten und globalen sozialen Initiativen.

Beschreibung

• Serve as the primary contact point between the Sponsor and assigned Investigational Sites • Ensure inspection readiness and compliance with clinical trial protocols, company SOPs, GCP, regulations, and guidelines from study start-up through site closure • Assist with site selection, qualification assessment, subject recruitment and retention planning, site initiation, monitoring, and close-out activities • Partner with the Local Trial Manager, Clinical Trial Assistant, and Trial Delivery Leader on overall site management • Act as the primary local company contact for assigned sites • Participate in site feasibility, Site Qualification Visits, and investigator meetings • Execute site initiation, start-up, remote and on-site monitoring, site management, and close-out activities • Implement analytical risk-based monitoring and resolve issues identified during monitoring visits • Ensure site staff training records are complete and accurate • Collaborate with the central study team to activate sites efficiently • Contribute to recruitment strategy, contingency planning, and implementation • Ensure study supplies and clinical drug supplies are adequate, properly handled, stored, inventoried, documented, and destroyed when appropriate • Ensure timely data entry and query resolution and verify data accuracy, validity, and completeness • Ensure Adverse Events, Serious Adverse Events, and Product Quality Complaints are reported and documented within required timelines • Maintain complete, accurate, and timely trial data and essential documents in relevant systems • Document trial activities, write visit reports and follow-up letters, and communicate status and issues to stakeholders • Review study files for completeness and ensure archiving requirements are met • Collaborate with the Local Trial Manager on site/study progress, issues, CAPA, and quality matters • Participate in team meetings and trainings and provide feedback or meeting leadership as needed • Act as a local expert in assigned protocols and develop sufficient therapeutic knowledge • Prepare sites for close-out and conduct final close-out visits • Track site-level costs and ensure payments are made where applicable • Maintain working relationships with investigators, trial coordinators, site staff, and internal stakeholders • Participate in Health Authority and IEC/IRB submission and notification processes as appropriate • Contribute to process improvement and training

🎯 Anforderungen

• Minimum Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or a related scientific discipline • Minimum 1 year of clinical trial monitoring experience • Basic working knowledge of GCPs, company SOPs, local laws and regulations, assigned protocols, protocol-specific procedures, and monitoring guidelines • Strong computer skills in appropriate software applications and related clinical systems • Strong written and oral communication skills • Willingness to travel up to 60% with overnight stays away from home • Valid Driver's License issued in one of the 50 United States • Good driving record • Oncology therapeutic-area experience preferred • Phase II and Phase III clinical trial experience preferred

🏖️ Vorteile

• Consolidated retirement plan (pension) • Savings plan (401(k)) • Long-term incentive program • Vacation – 120 hours per calendar year • Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington • Holiday pay, including Floating Holidays – 13 days per calendar year • Work, Personal and Family Time – up to 40 hours per calendar year • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child • Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year • Caregiver Leave – 80 hours in a 52-week rolling period • 10 days Volunteer Leave – 32 hours per calendar year • Military Spouse Time-Off – 80 hours per calendar year • Inclusive interview process and accommodations for applicants with disabilities