MSD saraton, yuqumli kasalliklar, yurak-qon tomir va metabolik holatlar, shuningdek, profilaktik tibbiy yordam kabi muhim sog‘liq muammolariga qarshi dori vositalari va vaksinalarni ishlab chiqadigan global biofarmatsevtika kompaniyasidir. Amerika Qo‘shma Shtatlari, Kanada va Puerto-Rikoda Merck & Co., Inc. nomi bilan tanilgan MSD ilmiy tadqiqotlarni ishlab chiqish va tijoriy tajriba bilan birlashtirib, odamlar va hayvonlar uchun tibbiy yechimlarni taqdim etadi.
Kompaniya faoliyati Inson salomatligi, Hayvonlar salomatligi hamda Tadqiqot va ishlanmalar yo‘nalishlarini qamrab oladi. Bu ilmiy, klinik, tijoriy, operatsion va korporativ jamoalarda faoliyat yurituvchi mutaxassislar uchun imkoniyatlar yaratadi. Dunyoning turli hududlarida faoliyat olib boradigan MSDdagi martaba imkoniyatlari tadqiqot, hamkorlik, inklyuzivlik va global salomatlik sohasidagi mas’uliyatli taraqqiyotga e’tiborni aks ettiradi.
Clinical Research Associate, Immunology — Remote in New Jersey
MSD seeks a remote Clinical Research Associate to monitor immunology trials, manage sites, uphold compliance and protocol standards, and build investigator relationships. The role requires approximately 65%–75% travel.
Tavsif
- Oversee performance and compliance for assigned protocols and clinical sites within the country
- Ensure study conduct meets ICH/GCP, country regulations, company procedures, quality standards, and adverse event reporting requirements
- Serve as the primary site contact and manager throughout every phase of clinical research studies
- Expand the clinical research territory by identifying and developing new sites
- Contribute subject-matter expertise on monitoring processes and systems in internal meetings and workstreams
- Build strong site relationships and maintain continuity across all trial phases
- Manage and monitor clinical study sites in accordance with applicable standards, regulations, protocols, and monitoring plans
- Develop thorough knowledge of study protocols and associated procedures
- Coordinate sponsor-role tasks to achieve Site Ready status
- Participate in site selection and validation activities
- Conduct remote and on-site monitoring and oversight
- Complete validation, initiation, monitoring, and close-out visits, along with timely visit and non-visit contact reports
- Collect, review, and monitor regulatory documentation through study start-up, maintenance, and close-out
- Communicate with investigators and site staff about protocol conduct, recruitment, retention, deviations, regulatory records, audits or inspections, and site performance
- Identify, evaluate, resolve, and escalate site performance, quality, and compliance concerns
- Collaborate with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional and headquarters teams, vendors, IRBs or IECs, and regulatory authorities
- Maintain study information and documentation in CTMS, eTMF, and other systems
- Strengthen CRA team knowledge by serving as a process SME, buddy or mentor, and sharing best practices
- Support or lead audit and inspection activities
- Conduct co-monitoring visits when appropriate
- Identify prospective sites and help build their clinical research capabilities
Talablar
- Associate degree, certificate, or equivalent in a scientific or healthcare discipline plus at least five years of relevant healthcare experience, including two years of direct site management or monitoring experience in a biotechnology, pharmaceutical, or CRO organization; alternatively, a bachelor’s degree or higher plus at least two years of direct site management or monitoring experience in a biotechnology, pharmaceutical, or CRO organization
- Immunology experience is preferred
- Ability to travel domestically and internationally approximately 65%–75% of working time, typically two to three days per week
- Current driver’s license required
- Fluency in local languages and English, both verbal and written
- Working knowledge of clinical research, clinical trial phases, current GCP/ICH standards, and country-specific clinical research laws and guidelines
- Working knowledge of global and country or regional clinical research guidelines
- Practical knowledge of Good Documentation Practices
- Demonstrated site management expertise, including site performance and patient recruitment
- Strong monitoring skills with the ability to exercise independent professional judgment
- Good IT proficiency, including Microsoft Office and clinical IT applications on computers, tablets, and mobile devices
- Ability to interpret and analyze data and metrics and respond appropriately
- Ability to manage complex issues using a solution-oriented approach
- Experience with root cause analysis and preventive or corrective actions
- Effective time management, organization, interpersonal communication, conflict management, and problem-solving skills
- Ability to work independently across multiple protocols, sites, and therapeutic areas
- Ability to prioritize and manage multiple tasks simultaneously
- Ability to work effectively in a multicultural matrix environment while maintaining culturally sensitive relationships
- Customer-focused approach with a strong commitment to quality and compliance
- Positive, growth-oriented mindset with strong self-direction
- Professional conduct and communication aligned with organizational policies and practices
- Applicants must reside in the United States or Puerto Rico
- Visa sponsorship is unavailable
Imtiyozlar
- Annual bonus
- Long-term incentive, where applicable
- Medical coverage for employees and their families
- Dental coverage for employees and their families
- Vision coverage for employees and their families
- Additional insurance coverage for employees and their families
- Retirement benefits, including a 401(k) plan
- Paid holidays
- Vacation leave
- Compassionate leave
- Sick leave
- Remote work arrangement
- Relocation is not provided