Clinical Trial Assistant (Sponsor Experience)

Under the direction of the Director, Clinical Trial Management, the Clinical Trial Associate (CTA) / Senior CTA assists the clinical research team members in ensuring effective and efficient conduct of clinical research studies by providing administrative and project tracking support in clinical development, including project set up, clinical study start up, site management and site closure.

The CTA will assist the team in the preparation of documents related to the implementation and execution of clinical trials. S/he will implement, maintain and archive study files according to our clients Standard Operating Procedures. The responsibilities will also include, but not be limited to, setting up databases, creating and editing documents, tracking and any other administrative tasks required to support the team.

Key Deliverables:

• Clinical trial documents
• Clinical trial tracking
• Clinical monitoring outputs
• Clinical project management outputs

Responsibilities:

• To provide general administrative support to the clinical research team members in the conduct of clinical studies.
• To assist the clinical research team members in its interaction with CROs/vendors.
• To assist in gathering, reviewing, and preparing clinical trial application documents for submission and approval from the competent authority and ethics committees; and to gather essential documents for the activation of sites.
• To be familiar with ICH GCP, appropriate regulations, relevant SOPs and internal tracking systems.
• To be familiar with the role of the Clinical Research Associates (CRA) including attending site visits, if appropriate.
• To assist clinical research team members with generation and review of study specific documentation and plans as appropriate.
• To set up, organize and maintain clinical study documentation (e.g. Trial Master Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
• To assist in quality control review of clinical study documentation (e.g. Trial Master Files, CRF Files, Monitoring Files, etc.).
• To coordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate.
• To assist clinical research team members with trial progress tracking by updating the Clinical Trial Management systems and other tools such as Excel spreadsheets.
• To address and route incoming correspondence, internal documentation, CRFs, etc., as appropriate.
• To contact clinical sites and CROs for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, clinical supplies status, etc.).
• To assist in the tracking and distribution of reports (e.g. metrics, safety reports, status communications) to internal/external stakeholders as directed.
• To co-ordinate document translation, if required.
• To facilitate and attend project team meetings and generate meeting minutes.
• To assist the clinical research team members and CRO with Investigator Meeting coordination, activities preparation and generate meeting minutes.
• To assist in the production of PowerPoint slides as needed for project, departmental, and/or vendor presentations.
• To assist with review and format of documents such as the Investigator Brochure, study protocol, publications etc.
• Other duties as assigned.

Requirements / Qualifications:

• Bachelor’s degree in Life Sciences or related field
• At least two years of experience working for a Clinical Research Department in the Pharmaceutical industry
• Must be familiar with ICH GCP guidelines and local regulatory requirements, as well as general understanding of clinical research principles and processes
• Good organizational skills, ability to manage multiple tasks, and meticulous attention to details.
• Strong interpersonal, written, and verbal communication skills.
• Demonstrates initiative, a sense of responsibility, autonomy, flexibility, and team spirit.
• Proficient in the use of the Microsoft Office suite of products, including Word, Excel, PowerPoint, Outlook, and Teams.
• Experience with clinical trial software such as EDC, eTMF, IRT, and CTMS.