Sr Clinical Research Associate
J
JobgetherClinical Research
Based in United StatesFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- At least 36 months of on-site clinical monitoring experience
- Required Skills
- Microsoft Office
Requirements
- Bachelor’s degree in Life Sciences or a related discipline, or an equivalent combination of industry and clinical research experience.
- Minimum 36 months of on-site clinical monitoring experience, including selection, initiation, management, and monitoring.
- Strong knowledge of medical terminology, clinical research processes, regulatory requirements, and clinical trial guidelines.
- Familiarity with clinical research technology, including CTMS, eTMF, EDC, and Microsoft Office.
- Strong critical-thinking, problem-solving, and issue-resolution skills.
- Excellent written and verbal communication skills in English.
- Proven ability to produce highly accurate documentation and meet strict deadlines.
- Strong organizational skills and ability to manage multiple site activities in a fast-paced environment.
- Ability to work independently and collaboratively with diverse stakeholders.
- Willingness and ability to travel up to 80% throughout North America.
Responsibilities
- Conduct remote and on-site monitoring activities in accordance with study protocols, project-specific monitoring plans, and regulations.
- Manage site activities including selection, initiation, ongoing monitoring, issue follow-up, and closeout.
- Maintain accurate study information in the Clinical Trial Management System (CTMS).
- Monitor data entry within Electronic Data Capture (EDC) systems and assist with eCRF queries.
- Perform Investigational Product reconciliation and review Investigator Site Files.
- Mentor, train, and assess junior Clinical Research Associates.
- Collaborate with project teams, investigators, and stakeholders to support study delivery.
- Travel extensively across North America, with up to 80% travel expected.
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