The Clinical Trial Specialist

The Clinical Trial Specialist (CTS) will be a member of the Clinical Operations team. This role is at the Coordinator/Associate CTM level.

They will have the following key 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 SOPs.
• May assist with vendor oversight and management with guidance.
• Identify issues in a timely manner and escalate to management as appropriate.
• May complete monitoring visit report review and perform co-monitoring or monitoring oversight visits.

Essential Functions:

• Support Phase 1, 2, 3 and 4 clinical studies with guidance.
• 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 (including but not limited to Informed Consent Forms, study manuals, site materials, training materials, pharmacy, and laboratory related manuals, etc.).
• Study Trial Master File (TMF) oversight.
• Ensure that the required study documents are received, reviewed, and filed in the TMF in accordance with SOPs, GCP, and applicable regulations.
• Organise study-related meetings, including but not limited to the preparation of the agenda/minute taking, and maintenance of risk/issue/decision logs.
• May lead and present 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, including but not limited to study status, enrolment, site queries, deviations, study levels documents and plans, etc.
• 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.).
• Work cross-functionally and provide oversight of CRO and vendor activities, including vendor management as assigned.
• Review and verification of contracted vendor activities, including vendor invoice review.
• Support study reporting and tracking with applicable systems and technology.
• Support study leads in the cross-functional alignment of study timelines.

Required Knowledge, Skills, and Abilities:

• At least 2 years of experience (3 years 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.
• Travel of 10% to 20% may be required.

Required/Preferred Education and Licenses:

• BA/BS, nursing degree or equivalent required, science major preferred.
• Relevant clinical trials experience is preferred.