Clinical Trial Specialist – Associate Clinical Operations Leader
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Job Description
Clinical Trial Specialist supporting clinical studies in a remote capacity at Parexel. Collaborating with clinical teams to ensure adherence to Good Clinical Practices.
Responsibilities:
- Support activities related to study/site feasibility, start-up, maintenance, and close-out.
- Manage study and site essential document review, collection, tracking, etc. from study start-up through maintenance and close-out.
- With guidance, support the Study Lead (CTM, AD, etc.) to prepare and maintain study documents and manuals as applicable.
- Study Trial Master File oversight, review and filing.
- Organise study related meetings including but not limited to preparation of agenda/ minute taking and maintenance of risk/ issue/ decision logs. (Occasionally this may involve leading and presenting at study-related meetings).
- May perform applicable site monitoring / co-monitoring visits (ad hoc, pre-study, initiation, routine monitoring close-out visits).
- Provides rapid action to address both internal and site QA findings from audits.
- May manage, coordinate, and oversee the activities from third party vendors including deliverables metrics, accruals, process planning, and implementation.
- General study tracking and maintenance and study site oversight including but not limited to site performance, metrics, monitoring report review, etc.
- Assist and support study data related activities including data review, query creation and resolution, study and protocol deviation reviews, safety reviews, etc.
- Routinely support and participate in department and clinical trial team meetings and participate in collaborative efforts (e.g., protocol development, CRO selection, departmental initiatives, etc.).
- Review and verification of contracted vendor activities including vendor invoice review.
Requirements:
- Bachelor’s, nursing degree or equivalent required, science preferred.
- 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.
- Advanced knowledge of Word, Excel, and PowerPoint.
- 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
- Paid time off
- Professional development opportunities
- Flexible working hours
- Inclusive work environment
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