Research Associate developing ultrasensitive immunoassays for biotech startup Spear Bio. Collaborating on innovative assay programs and advancing biomarker detection in early disease diagnosis.
About the role
- Clinical Research Associate conducting monitoring and oversight for clinical trials ensuring compliance and regulatory standards at ProPharma. Requires strong communication skills and at least 3 years of experience.
Responsibilities
- 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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