Clinical Trial Specialist
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Job Description
Providing technical and administrative support to clinical study teams at Parexel for clinical trial execution. Ensuring compliance with Good Clinical Practice and relevant SOPs in clinical studies.
Responsibilities:
- 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
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