Lead Clinical Study Assistant

Proclinical is advertising a vacancy for a Lead Clinical Study Assistant (CSA) to join a global workforce management solutions company. Specialising in multiple scientific and engineering sectors, this company is looking for someone to come onboard their California-based team.

The Lead Clinical Study Assistant will provide subject matter expertise across clinical study support and assist staff to solve non-routine problems. They will train new employees and prove continuing instructions to improve technique and knowledge. Working with Clinical Operations management, the Lead CSA will monitor and balance the department's workload across multiple projects to alleviate overload and minimise overtime. They will assist management in the re review of department procedures and recommend policy changes in response to both internal and external requests.

Job Responsibilities:

• Complying with applicable Corporate and Divisional Policies and procedures.
• Advising in decisions regarding work processes or operational plans and schedules in order to achieve department objectives of volume, quality, and compliance
• Providing guidance and feedback to team concerning outstanding issues.
• Balancing workflow based on vacations, sick time, and meetings to minimise backlog and overtime.
• Supervising and guiding the activities of in-house CSAs.
• Establishing priorities and assignments for the in-house CSAs.
• Providing mentoring and ongoing feedback on performance to staff.
• Serving as internal support for all members of Clinical Operations.
• Supporting investigative sites towards completion and appropriate submissions of all required clinical trial documents prior to site initiation.
• Supporting establishment and maintenance of the electronic Trial Master Files (eTMF).
• Coordinating Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate.
• Supporting overall progress of clinical trials by regularly attending clinical trial team meetings, reviewing team communications and sharing pertinent information with assigned investigative sites, as requested by the Study Manager, Lead CRAs, CRAs and other clinical trial team members.
• Assisting clinical trial teams to ensure that each clinical trial maintains audit/inspection readiness at each site and internally throughout the duration of assigned clinical trials.
• Ensuring all equipment/supplies provided to investigative sites are appropriately tracked and reported to Study Manager and/or Lead CRA during study start-up, maintenance and closeout.
• Assisting the study team with study start-up procedures, including preparing site binders.

Skills and Requirements:

• A BS/BS, or equivalent years of experience required.
• Knowledge of ophthalmology highly desirable, but not required.
• Working knowledge of GCPs.
• An ability to problem-solve.
• Excellent communicative skills, in written and verbal form.
• An ability to report to corporate offices for routine daily work.
• An ability to successfully manage multiple competing priorities and adapt quickly to changing priorities.
• Ability to problem-solve.
• Proficiency with MS Word, Excel and PowerPoint.
• Strong ability to supervise
• Works well in teams and with multiple internal and external contacts.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Maya Smith on +267-405-6995 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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