Clinical Research

• Design clinical trials, provide oversight, and support site and subject retention
• Ensure completion of clinical trial protocols, investigator brochures, monitoring plans, site training materials, clinical study reports, health authority responses, standard operating procedures, and related documents
• Participate on study teams and cross-functional teams as delegated by the Vice President, Clinical Development
• Ensure consistent use of language and criteria across multiple endocrine projects
• Ensure study integrity and track accumulating safety and efficacy data
• Anticipate clinical trial obstacles and implement solutions
• Analyze, evaluate, and support accurate interpretation and reporting of clinical data
• Draft and review clinical documents, manuscripts, presentations, and regulatory submissions
• Maintain current knowledge of relevant science, medical information, good clinical practices, and regulatory guidance
• Collaborate with cross-functional colleagues as a clinical research resource to optimize product development
• Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders
• Support corporate strategic and organizational initiatives
• Assist with commercial activities as needed
• Complete assigned tasks thoroughly, accurately, and on time
• Adhere to rigorous ethical standards
• Travel up to 20% domestically and internationally for scientific meetings

Clinical Scientist

• Ensure performance and compliance for assigned protocols and sites in the country
• Ensure study conduct complies with ICH/GCP, country regulations, company policies, quality standards, and adverse event reporting requirements
• Act as primary site contact and site manager throughout all phases of clinical research studies
• Develop and expand the clinical research territory by finding and developing new sites
• Develop strong site relationships and maintain continuity throughout trial phases
• Perform clinical study site management and monitoring activities
• Gain in-depth understanding of study protocols and related procedures
• Coordinate tasks with sponsor roles to achieve site readiness
• Participate in site selection and validation activities
• Perform remote and on-site monitoring and oversight activities
• Conduct validation, initiation, monitoring, and close-out visits; document visit and non-visit contact reports
• Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out
• Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, deviations, documentation, audits/inspections, and site performance
• Identify, assess, resolve, and escalate site performance, quality, and compliance issues
• Partner with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters functions, vendors, IRBs/IECs, and regulatory authorities
• Maintain information and documentation in CTMS, eTMF, and other systems
• Contribute as a process SME, buddy/mentor, and best-practice sharer
• Support or lead audit and inspection activities
• Perform co-monitoring visits where appropriate
• Identify potential new sites and help develop their clinical research capabilities

Clinical Research Associate – Vaccine, Infectious Disease

• Ensure performance and compliance for assigned protocols and sites in the country
• Ensure study conduct compliance with ICH/GCP, country regulations, company policies, quality standards, and adverse event reporting requirements
• Act as primary site contact and site manager throughout all phases of clinical research studies
• Develop and expand the clinical research territory by finding and developing new sites
• Participate in internal meetings and workstreams as a subject matter expert for monitoring processes and systems
• Develop strong site relationships and ensure continuity throughout all trial phases
• Perform clinical study site management and monitoring in compliance with ICH-GCP, SOPs, local laws, regulations, protocols, and monitoring plans
• Coordinate tasks with sponsor roles to achieve site readiness
• Participate in site selection and validation activities
• Perform remote and on-site monitoring and oversight activities
• Conduct validation, initiation, monitoring, and close-out visits; document visit and non-visit contact reports
• Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out
• Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, deviations, documentation, audits/inspections, and site performance
• Identify, assess, resolve, and escalate site performance, quality, and compliance issues
• Partner with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters teams, vendors, IRBs/IECs, and regulatory authorities
• Manage and maintain information and documentation in CTMS, eTMF, and other systems
• Contribute as a process SME, buddy/mentor, and best-practice contributor
• Support and/or lead audit and inspection activities
• Perform co-monitoring visits
• Identify potential new sites and help develop their clinical research capabilities

Clinical Research Associate – Oncology

• Conduct site selection, initiation, routine monitoring, and close-out visits according to the monitoring plan
• Verify informed consent procedures and protection of patient rights and safety
• Perform source data verification (SDV) and source data review (SDR)
• Review and reconcile clinical trial data against source documents
• Query and resolve data discrepancies with site staff
• Monitor investigational product accountability, storage, and dispensing
• Assess site compliance with the protocol, ICH-GCP, and applicable regulations
• Identify, document, and escalate protocol deviations, adverse events, and serious adverse events
• Maintain and review the Trial Master File (TMF) and site regulatory files
• Build and maintain relationships with investigators, site coordinators, and study staff
• Track site performance metrics, including enrollment, query resolution, and data entry timelines
• Prepare monitoring visit reports and follow-up letters
• Support site staff training on protocols, study procedures, and data entry systems
• Assist with audit and regulatory inspection preparation and follow-up
• Act as the primary point of contact between the sponsor/CRO and investigative sites
• Safeguard data integrity and patient safety throughout the trial lifecycle
• Uphold the organization’s mission, values, and commitment to ethical research
• Participate in training, team meetings, quality improvement, accountability, collaboration, and continuous learning activities

Clinical Research Associate

• Maintain study inventory
• Assist with biospecimen collection and processing
• Support logistics related to clinical trial conduct
• Ensure study kits, investigational devices, and general research supplies are appropriately stocked, organized, and tracked
• Assist with phlebotomy
• Handle and ship specimens
• Perform data entry
• Document research procedures to support protocol compliance and data integrity
• Support the clinical research team

Clinical Research jobs in New Jersey

Clinical Scientist

Clinical Research Associate – Vaccine, Infectious Disease

Clinical Research Associate – Oncology

Clinical Research Associate

Clinical Research Support Assistant – Full Time – Day – Clinical Trials