обновлено 12 часов назад
Senior Clinical Research Associate (Clinical Monitoring)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Research Associate (Clinical Monitoring): Overseeing clinical monitoring and site management for complex studies through feasibility, site visits, protocol compliance, source data verification, and audit-ready documentation with an accent on ICH-GCP, regulatory requirements, and stakeholder coordination. Focus on leading complex-site oversight, resolving data and protocol issues, developing study-specific monitoring documents, and training or coordinating CRAs.
Location: Remote within the United States; candidates must reside in a U.S. state where is authorized to hire. Residents of California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and the District of Columbia are not eligible.
Company
provides end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy for biopharmaceutical sponsors.
What you will do
- Oversee clinical monitoring and site management in compliance with GCP, global regulations, protocols, and company SOPs.
- Contribute to study documents, lead site feasibility activities, and recommend sites for selection.
- Plan and conduct site initiation, routine monitoring, and close-out visits, including on-site and remote activities.
- Verify source data, CRFs, investigational product accountability, safety documentation, and protocol deviations while keeping site files audit-ready.
- Manage data queries, corrective and preventive actions, action items, monitoring deliverables, and issue trends.
- For assigned Lead CRA responsibilities, develop study-specific monitoring documents, finalize visit reports, train and coordinate CRAs, and act as the primary monitoring contact for project managers and sponsors.
Requirements
- Bachelor’s degree in life sciences, nursing, or a related field preferred.
- 5–7+ years of experience conducting on-site and remote monitoring visits, or equivalent clinical research experience; complex study experience is required.
- Broad therapeutic exposure across multiple study types and indications, with strong scientific and medical terminology knowledge.
- Advanced organizational, logistical, communication, and stakeholder-management skills, including the ability to manage multiple sites and protocols within timelines and budgets.
- Experience training, coaching, and mentoring clinical research staff; proficiency with Microsoft Office and EDC systems.
- Willingness to travel up to 80% and ability to remain stationary for extended periods, with reasonable accommodations considered where appropriate.
Culture & Benefits
- Medical, dental, and vision insurance.
- FSA, HSA, critical illness, hospital indemnity, accident, disability, and life insurance options.
- 401(k) safe harbor plan with company match.
- Paid vacation, holidays, sick time, volunteer time, and maternity and paternity leave.
- Initiatives supporting wellness, professional growth, development, and team relationships.
- Inclusive work environment focused on integrity, accountability, respect, and collaboration.
Hiring process
- Submit an English resume through the Careers Portal or LinkedIn Easy Apply.
- An Upwage AI screener may be used as part of the application review; selected candidates proceed to interviews with the team.
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