MSD este o companie biofarmaceutică globală care dezvoltă medicamente și vaccinuri pentru provocări majore din domeniul sănătății, inclusiv cancerul, bolile infecțioase, afecțiunile cardiovasculare și metabolice, precum și îngrijirea axată pe prevenție. Cunoscută sub numele Merck & Co., Inc. în Statele Unite, Canada și Puerto Rico, MSD îmbină cercetarea științifică cu expertiza în dezvoltare și comercializare pentru a oferi soluții de îngrijire a sănătății oamenilor și animalelor.
Activitatea sa acoperă domeniile Sănătății Umane, Sănătății Animalelor și Cercetării și Dezvoltării, creând oportunități pentru profesioniști din echipe științifice, clinice, comerciale, operaționale și corporative. Prin activitățile desfășurate în regiuni din întreaga lume, carierele la MSD reflectă accentul pus pe cercetare, colaborare, incluziune și progres responsabil în domeniul sănătății globale.
Clinical Research Associate, Neurology (Remote in New Jersey)
Remote Clinical Research Associate role supporting neurology trials for MSD through site oversight, compliance monitoring, documentation, and investigator collaboration across study phases.
Descriere
- Oversee performance and compliance for assigned protocols and country sites
- Ensure studies follow ICH/GCP, local 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 additional study sites
- Join internal meetings and workstreams as a monitoring-process subject matter expert
- Build productive site relationships and maintain continuity throughout all trial phases
- Manage and monitor clinical study sites in accordance with ICH-GCP, sponsor SOPs, local requirements, protocols, monitoring plans, and related documents
- Coordinate sponsor activities to achieve site readiness
- Contribute to site selection and validation decisions
- Perform remote and on-site monitoring and oversight
- Conduct validation, initiation, monitoring, and close-out visits, documenting visit and non-visit contacts accurately and promptly
- Collect, review, and track regulatory documentation during study start-up, maintenance, and close-out
- Discuss protocol conduct, recruitment, retention, deviations, documentation, audits, inspections, and site performance with investigators and site staff
- Identify, evaluate, resolve, and escalate site performance, quality, and compliance issues
- Collaborate with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional and headquarters teams, vendors, IRB/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 best-practice contributor
- Support or lead audit and inspection activities
- Conduct co-monitoring visits when appropriate
- Identify prospective sites and help build their clinical research capabilities in line with country strategy
Cerințe
- Associate degree, certificate, or equivalent scientific or healthcare qualification plus at least five years of relevant healthcare experience, including two years of direct site monitoring in biotechnology, pharmaceutical, or CRO settings; alternatively, a bachelor's degree or higher plus at least two years of direct site monitoring experience in biotechnology, pharmaceutical, or CRO settings
- Neurology experience is preferred
- Fluency in local languages and English, both spoken and written
- Working knowledge of clinical research, trial phases, current GCP/ICH standards, and applicable country laws and guidelines
- Understanding of global and country or regional clinical research guidelines
- Practical knowledge of Good Documentation Practices
- Demonstrated site management ability, including oversight of site performance and patient recruitment
- Advanced monitoring capability with sound independent professional judgment
- Strong IT proficiency, including Microsoft Office and clinical applications used on computers, tablets, and mobile devices
- Ability to interpret and analyze data and performance metrics
- Ability to manage complex issues using a solution-focused approach
- Experience with root-cause analysis and preventive or corrective actions
- Strong time management, organization, interpersonal communication, conflict management, problem-solving, and prioritization skills
- Ability to work independently across multiple protocols, sites, and therapeutic areas
- Ability to collaborate effectively in a multicultural matrix environment while maintaining culturally sensitive relationships
- Customer-focused approach with a strong commitment to quality and compliance
- Willingness and ability to travel domestically and internationally for approximately 65% to 75% of working time, typically two to three days per week
- Current driver's license preferred
Beneficii
- Annual bonus
- Long-term incentive, where applicable
- Medical, dental, and vision coverage
- Additional insurance coverage for employees and families
- Retirement benefits, including a 401(k) plan
- Paid holidays
- Vacation time
- Compassionate leave
- Sick leave
- Remote work arrangement