Clinical Research Specialist Jobs

Evaluates and analyzes clinical data.

• Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings.
• Roles typically require a university degree or an extensive amount of practical knowledge gained through experience.
• This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.
• Conducts clinical monitoring of field sites to supervise and coordinate clinical studies.
• Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives.
• Must have knowledge in reference to good clinical practices regulations and standard operating procedures.
• This job typically requires a Bachelor degree
• Job requires an understanding and application of procedures and concepts of own discipline.
• May draft materials including informed consent documents, draft source documents, patient instruction guides and case report forms.
• The job requires the ability to make judgements based on practice and previous experience.
• May write protocols.

• Familiar GDP (good documentation practices)
• Working as CRA (clinical research associate.)
• Preferred, experience with electronic file system, Medidata and SharePoint & Smartsheet.
• 5+ years, BA required.
• Filling clinical trial documents ETMF

Day to Day:

• Will work closely with Clinical Controls and Clinical Operations team members to ensure the timely QC approval or remediation of clinical trial essential documents based on GDP standards, the project MF Index, and Client SOPs.
• Review docs from the site an determine if the docs are complete, accurate and named appropriately and filed in the correct area (QA) if not correct and let the team know.