Senior Clinical Research Associate
C
ClinChoiceClinical Research
Remote, United StatesFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- At least eight (8) years of clinical research experience
- Required Skills
- GCPMicrosoft Office
Requirements
- University Degree in scientific, medical or paramedical disciplines.
- At least eight (8) years of clinical research experience.
- Proven experience as a Clinical Research Associate (CRA) performing on-site monitoring.
- Previous experience working for a CRO is required.
- Experience monitoring oncology, respiratory, and complex clinical trials.
- Strong knowledge of clinical trial operations, GCP, and ICH Guidelines.
- Proficiency in Microsoft Office suite (Word, Excel, Outlook).
- Fluent in English and local language(s).
- Willingness to travel to investigative sites as needed.
Responsibilities
- Manage 2–3 clinical trials including study start-up, site monitoring, and closeout.
- Conduct on-site and remote monitoring visits and complete monitoring visit reports.
- Perform source data verification (SDV) and ensure quality and completeness of Case Report Forms (CRFs).
- Train site staff in study procedures and manage investigational products and trial materials.
- Support safety reporting, including AEs, SAEs, and SUSARs, ensuring timely follow-up.
- Act as the primary contact for study sites to ensure proper execution of protocols.
- Conduct study termination and archiving activities.
- Mentor and supervise Clinical Research Associate I (CRA I) staff.
- Assist with study site feasibility, budget negotiations, and submission processes.
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