Clinical Trial Specialist
Parexel
full-time
Posted on:
Location Type: Remote
Location: United Kingdom
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Tech Stack
About the role
- Support moderately complex clinical study activities in support of the Clinical Trial Manager.
- Work closely with the clinical trial team to ensure trial activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's.
- May assist with vendor oversight and management with guidance.
- Identify issues in a timely manner and escalate to management as appropriate.
- Oversight of TMF
- May complete monitoring visit report review and perform co-monitoring or monitoring oversight visits.
Requirements
- At least 2 years of experience (3yrs preferred) in clinical studies (Pharmaceutical Industry Experience Preferred).
- Previous site monitoring or study coordinator experience is preferred.
- Working knowledge of Good Clinical Practices (GCP) regulations and Standard Operating Procedures.
- Understanding of study phases and general knowledge of how they apply to clinical development.
- Demonstrated ability to work independently and in a team environment.
- Working knowledge of electronic Systems including Trial Master File, CTMS, etc. (e.g., Veeva Vault, Smartsheet, SharePoint, etc.).
- Knowledge of the principles and practices of computer applications in database management.
- Strong verbal and written communication skills required.
- 10% - 20% travel may be required.
Benefits
- Health insurance
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical study activitiessite monitoringstudy coordinationGood Clinical Practice (GCP)Standard Operating Procedures (SOP)monitoring visit report reviewmonitoring oversightdatabase management
Soft Skills
ability to work independentlyteam collaborationissue identificationescalation to managementstrong verbal communicationstrong written communication