Senior Clinical Trial Associate

Telix Pharmaceuticals•Fishers, IN

34d

About The Position

The Senior Clinical Trial Associate (SCTA) supports clinical studies and the Clinical Operations Department, in managing various administrative tasks such as generation of agenda and minutes, maintaining study tracking, eTMF management, filing and quality reviews of study documents as well as participating in process improvement initiatives across the department. The SCTA will play a key role in working cross functionally to support the clinical teams including close collaboration with study team from vendors/CROs in completing all required tasks to meet departmental and project goals. Strong candidates will bring knowledge and experience in the fundamental aspects of trial and study site management, vendor management, and experience in the full cycle of study from start- up to close out.

Requirements

Bachelor's degree (BSc, BA or RN equivalent) in a biological or science-related field is essential.
3+ years of experience and knowledge in ICH GCP, eTMF management and DIA TMF Reference Model.
Previous CTA experience working with Sponsors, CROs and/or vendors.
Experience of working effectively in a fast-paced team environment.
Proficiency in office suite notably Microsoft Word, Excel and PowerPoint, Veeva Vault and Smartsheet
Ability to develop and/or use existing tools (e.g. tracking tool).
Experience of working across functions.
Excellent organizational, interpersonal and communication skills
Ability to prioritize and manage multiple tasks with competing deadlines.
Willingness to travel as needed (<5%).

Responsibilities

Assists Clinical Project Managers (CPMs) with Sponsor oversight, study-specific documentation review, and QC, including ICF, study plans, study reference manuals, eCRF, etc.
Supports Investigator Initiated Trials (IITs) by providing oversight and operational support, including clinical supply forecasting, reoccurring meeting participation and preparation.
May be involved in study startup, acting as a startup specialist, and leading or being the point of contact for a CRO regarding site/institutional CDAs, site feasibility questionnaires, and startup documentation.
Liaises between internal medical affairs teams/MSLs and CRO/Sites.
May be the point of contact for documentation or specific requests (e.g., enrollment updates, missing documentation, meeting arrangements).
Supports trial submissions to applicable IRBs and regulatory health authorities, as required.
Assists with creating and maintaining study metrics trackers, tools, and reports.
Assists in coordinating and tracking Investigator and third-party payments.
Ensures required study documents are submitted to the study (electronic) trial master file ((e)TMF).
Conducts eTMF reviews for in-house studies in collaboration with the CPM.
Creates Investigator Site Files (ISF) for in-house studies.
Manages (e)TMF and study documents to meet GCP/ICH and internal guidelines for records retention.
Acts as a CLM Super User and facilitates contract execution and management in the system.
Assists CPMs with Sponsor oversight of CRO-held eTMFs, periodic audits, and findings resolution.
Assists with the customization of CDAs, clinical site contracts, and budgets, when applicable.
Assists CPMs and clinical teams with Investigator Meeting coordination and activity preparation.
Coordinates document translation, if required.
Acts as Veeva Vault owner and owns the training responsibilities to ensure that role-based training and access are granted to each internal and, when required, external stakeholder.
May participate in training CRO teams and onboarding new CRO team members.
Attends internal and external team meetings/teleconferences and generates meeting agendas and minutes when needed.
May assist in or conduct study monitoring, including site qualification visits, site initiation visits, interim monitoring, etc.
Other duties as assigned, including study monitoring.