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Duke CareersSenior Clinical Research Specialist
Clinical Research Specialist supporting clinical research operations at Duke University School of Medicine. Involves data management, participant recruitment, and compliance with study protocols.
About the role
- Responsible for conduct of all types of monitoring and co-monitoring visits for assigned clinical sites both in person and remote.
- Responsible for monitoring report writing and completion within required SOP and local regulatory parameters.
- Support development of study specific documentation related to monitoring activities as assigned.
- Responsible for site personnel management and training on protocol requirements.
- Responsible for source document and case report forms review for accuracy and integrity of the data.
- Monitoring assigned clinical trials and clinical sites by reviewing and reporting site enrollment and updates.
- Responsible for review and oversight of regulatory documentations for accuracy and completeness.
- Participate in meetings and conference calls with internal project teams, Sponsor teams, and external partners.
Requirements
- Bachelor's degree or equivalent combination of education and experience.
- At least 3 years of experience as a Clinical Research Associate.
- Prior therapeutic experience with Alzheimer's or similar Neurological/CNS therapeutic expertise.
- Excellent verbal, written communication skills and interpersonal skills.
- Excellent computer skills with experience using Microsoft Office (Outlook, Word, Excel, Power Point).
- Electronic data capture (EDC), CTMS, IVRS, and eTMF experience required.
- Knowledge of applicable local law, local regulatory requirements and regulations, ICH Guidelines, and GCPs governing clinical trials.
Benefits
- ProPharma celebrates diversity, equity, and inclusion.
- Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits.
- ProPharma does not rely on AI screening tools for hiring.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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