Clinical Research Associate
Novo Nordisk
5 days ago
On-site
Plainsboro, NJ
Clinical Research and Development
The Position (Phase 1 healthy volunteer studies): CRA/Sr. CRA drives quality clinical research and delivery of monitoring and site management activities, ensuring patient safety/rights and wellbeing, data reliability, scientific integrity, and regulatory/process compliance.
Essential Functions:
- Deliver tasks supporting planning and implementation of quality-driven clinical trials.
- Implement proactive risk identification/mitigation using RBQM; execute Site Selection, Site Initiation, Monitoring, and Closure.
- Verify safety reporting and proper handling/monitoring/storage of trial product per protocol, SOPs, ICH-GCP, and regulations.
- Ensure data accuracy, validity, and completeness per protocol/Monitoring Plan.
- Complete required training; act as local expert in assigned protocols; build therapeutic area knowledge.
- Drive recruitment and retention to meet enrollment/retention targets.
- Support audit/inspection activities; develop/implement CAPA.
- Collaborate and provide input across CDO/CMR/global partners; maintain technical proficiency.
Physical Requirements:
- 50–75% overnight travel; valid driver’s license; may work weekends/holidays. Territory: East Coast + Central US (near major airport ideal).
Qualifications/Skills:
- 4+ years clinical trial experience (pharma/biotech/CRO/healthcare) required; 2+ years on-site monitoring required (may be waived with relevant GCP Novo Nordisk experience).
- Bachelor’s degree (science preferred); alternatively RN with 3+ years on-site monitoring.
- Knowledge of medical terminology and ICH-GCP; ability to balance competing priorities and mitigate risks.
- Proficiency: MS Office, MS Project, MS PowerPoint.
- Excellent English communication; collaborative/stakeholder management.
- Preferred: Phase 1 healthy volunteer monitoring (on-site and remote).
Compensation/Benefits (as stated):
- Eligible for company bonus; long-term incentive and/or company vehicles (level dependent). Medical/dental/vision, life/disability, 401(k), flex spending, EAP, tuition reimbursement, voluntary benefits; sick time, flexible vacation, parental leave.
Application instruction:
- If needing accommodation, call 1-855-411-5290 (accommodation requests only).
Essential Functions:
- Deliver tasks supporting planning and implementation of quality-driven clinical trials.
- Implement proactive risk identification/mitigation using RBQM; execute Site Selection, Site Initiation, Monitoring, and Closure.
- Verify safety reporting and proper handling/monitoring/storage of trial product per protocol, SOPs, ICH-GCP, and regulations.
- Ensure data accuracy, validity, and completeness per protocol/Monitoring Plan.
- Complete required training; act as local expert in assigned protocols; build therapeutic area knowledge.
- Drive recruitment and retention to meet enrollment/retention targets.
- Support audit/inspection activities; develop/implement CAPA.
- Collaborate and provide input across CDO/CMR/global partners; maintain technical proficiency.
Physical Requirements:
- 50–75% overnight travel; valid driver’s license; may work weekends/holidays. Territory: East Coast + Central US (near major airport ideal).
Qualifications/Skills:
- 4+ years clinical trial experience (pharma/biotech/CRO/healthcare) required; 2+ years on-site monitoring required (may be waived with relevant GCP Novo Nordisk experience).
- Bachelor’s degree (science preferred); alternatively RN with 3+ years on-site monitoring.
- Knowledge of medical terminology and ICH-GCP; ability to balance competing priorities and mitigate risks.
- Proficiency: MS Office, MS Project, MS PowerPoint.
- Excellent English communication; collaborative/stakeholder management.
- Preferred: Phase 1 healthy volunteer monitoring (on-site and remote).
Compensation/Benefits (as stated):
- Eligible for company bonus; long-term incentive and/or company vehicles (level dependent). Medical/dental/vision, life/disability, 401(k), flex spending, EAP, tuition reimbursement, voluntary benefits; sick time, flexible vacation, parental leave.
Application instruction:
- If needing accommodation, call 1-855-411-5290 (accommodation requests only).