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MSD
MSD
Sponsor pentru viza H1BAsistență medicalăBiotehnologieLogistică

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.

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Locurile de muncă ale companiei

Clinical Research Associate - Immunology (Remote, New Jersey)

Remote Clinical Research Associate role supporting immunology trials for MSD, with responsibility for site oversight, compliance, documentation, and investigator relationships. Requires approximately 65–75% domestic and international travel.

USStatele Unite ale AmericiiNJNew Jersey
96.200 $ – 151.400 $ / an
RemoteNormă întreagăJuniorNivel mediuLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • Maintain performance and compliance across assigned protocols and clinical sites
  • Ensure studies follow ICH/GCP, local regulations, company policies, quality standards, and adverse event reporting requirements
  • Serve as the primary site contact and manager throughout each 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 trial phases
  • Manage and monitor clinical study sites in accordance with applicable requirements
  • Develop a thorough understanding of study protocols and related procedures
  • Coordinate with sponsor functions to achieve site readiness
  • Support site selection and validation activities
  • Conduct remote and on-site monitoring and oversight
  • Complete validation, initiation, monitoring, and close-out visits
  • Produce clear, comprehensive, and accurate 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, documentation, audits, inspections, and performance
  • 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, IRBs/IECs, and regulatory authorities
  • Maintain study information and documentation in CTMS, eTMF, and other systems
  • Share knowledge with the CRA team as a subject-matter expert, 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 strengthen their clinical research capabilities

Cerințe

  • Associate degree, certificate, or equivalent in a scientific or healthcare discipline with at least 5 years of relevant healthcare experience, including 2 years of direct site-monitoring experience in a biotechnology, pharmaceutical, or CRO setting; alternatively, a bachelor's degree or higher with at least 2 years of direct site-monitoring experience in a biotechnology, pharmaceutical, or CRO setting
  • Immunology experience is preferred
  • Ability to travel domestically and internationally for approximately 65%–75% of working time, typically 2–3 days per week
  • Valid driver's license
  • Fluency in local languages and English, both spoken and written
  • Understanding of clinical research, trial phases, GCP/ICH, and country-specific clinical research laws and guidelines
  • Understanding of global and country or regional clinical research guidelines
  • Knowledge of Good Documentation Practices
  • Demonstrated site management ability, including site performance and patient recruitment
  • Advanced monitoring skills and independent professional judgment
  • Strong IT skills, including Microsoft Office and clinical IT applications
  • Ability to interpret and analyze data and metrics
  • Ability to manage complex issues and conduct root cause analysis
  • Effective time management, organization, interpersonal communication, conflict management, and problem-solving skills
  • Ability to work independently across multiple protocols, sites, and therapy areas
  • Ability to work effectively in a multicultural matrix environment
  • Commitment to customer focus, quality, and compliance
  • Adverse Event Reporting System
  • Clinical Research
  • Clinical Research Methods
  • Clinical Site Management
  • Clinical Study Management
  • Clinical Trial Planning
  • Clinical Trials Monitoring
  • Cultural Awareness
  • Customer Centricity
  • Document Management
  • Good Clinical Data Management Practice (GCDMP)
  • Good Clinical Practice (GCP)
  • Matrix Management
  • On Site Management
  • Pharmaceutics
  • Protocol Adherence
  • Protocol Review
  • Regulatory Affairs Management
  • Regulatory Compliance
  • Regulatory Inspections
  • Relationship Building
  • Remote Monitoring
  • Site Management
  • Study Design

Beneficii

  • Annual bonus
  • Long-term incentive, where applicable
  • Medical, dental, and vision coverage
  • Additional insurance benefits for employees and families
  • Retirement benefits, including a 401(k) plan
  • Paid holidays
  • Vacation time
  • Compassionate leave
  • Sick leave
  • Remote work arrangement
  • No relocation

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