Senior Clinical Research Associate
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Job Description
Senior Clinical Research Associate managing oncology and complex clinical trials for ClinChoice, a global full-service CRO. Conducting site monitoring, data verification, safety reporting and study closeout.
Responsibilities:
- Manage 2–3 clinical trials and site management activities
- Conduct study start-up, site selection, site evaluation, initiation, monitoring and closeout activities
- Keep current with scientific, regulatory and operational aspects relevant to assigned clinical projects
- Train site staff in study procedures
- Conduct periodic on-site and remote monitoring visits and complete monitoring visit reports
- Review Case Report Forms for accuracy, legibility, completeness and quality
- Perform source data verification and in-house clinical data review
- Resolve data queries in a timely manner
- Manage investigational products and trial materials, including storage, inventory, dispensing records, packaging, labelling and study files
- Coordinate safety issue reporting and follow-up for AEs, SAEs and SUSARs
- Conduct and report study termination and archiving activities
- Serve as the main contact for investigative sites
- Support the Clinical Research Division with clinical data quality control
- Escalate issues that may jeopardize assigned clinical projects
- Report study activities and submit relevant documents to the Head of Department
- Develop training materials and deliver training with the Training & Qualification Management Unit
- Assist with site study budget contract negotiation after appropriate training
- Assist with CRF design/development, CRF instructions and study file organization
- Support project submissions, submission requirements, timelines and informed consent development
- Guide and supervise CRA I staff
Requirements:
- University Degree in scientific, medical or paramedical disciplines
- Previous experience working for a CRO is required
- At least eight (8) years of clinical research experience, including proven experience as a Clinical Research Associate performing on-site monitoring activities
- Experience monitoring oncology, respiratory and complex clinical trials is required
- Strong knowledge of clinical trial operations, GCP/ICH Guidelines and applicable regulatory requirements
- Fluent in English and local language(s)
- Proficiency in Microsoft Office, including Word, Excel and Outlook
- Willingness to travel to investigative sites as needed
Benefits:
- Permanent employment
- Fully remote position
- Continuous training and professional development
- Equal opportunity, diversity and inclusivity
- Opportunity to work on varied studies across pharmaceutical, biotechnology, medical device and consumer health clients
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