Professor / A Biologia

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Clinical Trial Associate II (CTAII) to join our A-team (office-based).

As a CTAII at Allucent, you are responsible for the primary administrative support to Allucent clinical study teams at Country / Site level, supporting Clinical Trial Operations and Sponsors, thus ensuring that the clinical trial is conducted in accordance with international regulatory and local regulatory and ethical laws, and guidelines for Good Clinical Practice and Standard Operating Procedures.

Your key tasks will include :

• Performing quality checks of documents prior to eTMF submission to ensure the documents meet specifications to be complete and accurate for filing.
• Acting as Document Submitter and submitting country and site level documents to eTMF Document Inbox. Resolving rejections.
• Assisting with resolution of periodic QC findings for country and site eTMF.
• If applicable, maintaining study wet-ink documents temporarily in the local office and preparing shipment to the client at the end of the study.
• Communicating with the TMF Lead / Project Specialist to follow-up on country and site level eTMF status.
• Updating Expected Documents List (EDL) in eTMF for the country and site level.
• Maintaining Public Folders in accordance with Study Correspondence Management Plan.
• Preparing and distributing Investigator Site Files (ISFs / eISFs), Pharmacy Site Files (PSFs / ePSFs) or other files needed for Site Initiation Visits (SIVs).
• Preparing and maintaining QC / Inventory Checklists for the ISFs / PSFs to support CRA with preparation for site visits and paperwork after site visits.
• Assisting CRA with reconciliation of ISF / PSF vs. TMF and cooperating with TMF Specialist and PS (Project Specialist) / TMF Lead to ensure inspection readiness of the TMF.
• Assisting CRAs / Clinical Trial Lead with query resolution and aged action item metrics follow up internally.
• Performing translations, back-translations or verification of translations of study documentation when needed.
• Accurately updating and maintaining site level CTMS, as needed.
• If needed, assisting the project team with CTMS reports at requested intervals to follow-up on pending entries.
• Preparing and maintaining country and sites related study trackers, as needed.
• In cases when CTA II is demonstrating high level of written and spoken English, he / she may be assigned to attend project specific teleconferences, prepare, and deliver TC minutes as requested.
• If needed, attending non-study related and executive teleconferences and preparing and distributing minutes for meeting attendees within agreed timelines.
• Preparing and distributing clinical trial supplies to the investigational sites and maintaining tracking information.
• As needed, communicating with sites regarding trial start-up, conduct, and close-out administrative activities.
• May participate in feasibility and / or site identification activities.
• Providing training and mentoring to new CTAs on Allucent procedures and clinical trial administration, as required.
• Obtaining quotes from local vendors (printing companies, translators, couriers) and providing information to the Project Specialist (PS) for obtaining approval from PM / CTL prior to placing orders.
• If needed, providing local support for organization of Investigator Meeting or any other study meeting organized in the country where CTA is located.
• Performing any other ad hoc administrative tasks not listed above to support team members with clinical trial execution, as required at Country / Site level.
• Providing administrative tasks to support Office Managers and Country Managers, as required.

Requirements

• Must be legally authorized to work in the country the role has been posted in and does not require sponsorship now or in the future for employment where the job is located in.
• High School Diploma / Certificate or equivalent combination of education, training and experience; bachelor’s degree or equivalence (BS / BA) preferred.
• Experience of at least 2 years as CTA I or within a similar role or at least 3 years as a clinical research coordinator.
• Good Clinical Practices Knowledge.
• Fluency in English (spoken and written).
• Strong verbal and written communication skills.
• Computer literacy, proficiency in Microsoft Office.
• Excellent interpersonal and organizational skills.
• Ability to work independently and to effectively prioritize tasks with some guidance and oversight.
• Ability to manage several projects.
• Ability to establish and maintain effective working relationships with co-workers and managers.
• Knowledge of medical terminology and clinical monitoring process.