IQVIA cFSP (sponsor-dedicated) are seeking a Senior CTA to join us on our mission to drive healthcare forward.
(Hybrid working with
3 days per week required on-site in Luton
with the sponsor, a global biopharmaceutical.) The Senior CTA will perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines. Collaborate with clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files and completeness. Collaborate with CRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation. Act as a mentor for less experienced Clinical Trial Assistants (CTAs). Assist with training and onboarding of new CTAs. May serve as subject matter expert for business processes. May lead CTA study teams. May assist with interviewing and screening of potential new team members. May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training. May participate in departmental quality or process improvement initiatives. Qualifications Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH). Minimum 6 months clinical research experience strongly preferred. Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint. Effective written and verbal communication skills including good command of English language. Effective time management and organizational skills. Ability to establish and maintain effective working relationships with coworkers, managers, and clients. *Please note - this role is not eligible for UK visa sponsorship*
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3 days per week required on-site in Luton
with the sponsor, a global biopharmaceutical.) The Senior CTA will perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines. Collaborate with clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files and completeness. Collaborate with CRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation. Act as a mentor for less experienced Clinical Trial Assistants (CTAs). Assist with training and onboarding of new CTAs. May serve as subject matter expert for business processes. May lead CTA study teams. May assist with interviewing and screening of potential new team members. May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training. May participate in departmental quality or process improvement initiatives. Qualifications Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH). Minimum 6 months clinical research experience strongly preferred. Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint. Effective written and verbal communication skills including good command of English language. Effective time management and organizational skills. Ability to establish and maintain effective working relationships with coworkers, managers, and clients. *Please note - this role is not eligible for UK visa sponsorship*
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