CLINICAL TRIAL ASSOCIATE II (SPAIN)

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.
e are looking for a Clinical Trial Associate II (CTA II) to join our A-team (hybrid).
As a Clinical Trial Associate II at Allucent, you are responsible for primary administrative support to Allucent clinical study teams at Country/Site level, to support 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.
Assists the study team with the day-to-day conduct of international clinical studies with the guidance of an experienced team member at Country/Site Level.
In this role your key tasks will include.
erforms quality check of documents prior to eTMF submission to ensure the documents meet specifications to be complete and accurate for filing.
After quality check acts as Document Submitter and submits country and site level documents to eTMF Document Inbox.
Resolves rejections.
Assists with resolution of periodic QC findings for country and site eTMF.
If applicable, maintains study wet-ink documents temporarily in the local office and prepares shipment to the client at the end of the study.
Communicates with the TMF Lead / Project Specialist to follow-up on country and site level eTMF status.
Updates Expected Documents List (EDL) in eTMF for the country and site level.
Maintains Public Folders in accordance with Study Correspondence Management Plan Prepares and distributes Investigator Site Files (ISFs/eISFs), Pharmacy Site Files (PSFs/ePSFs) or other files needed for Site Initiation Visits (SIVs).
Prepares and maintains QC/Inventory Checklists for the ISFs/PSFs to support CRA with preparation to site visits and paperwork after site visits.
Assists CRA with reconciliation of ISF/PSF vs.
TMF and cooperates with TMF Specialist and PS (Project Specialist)/TMF Lead to ensure inspection readiness of the TMF.
Assist CRAs /Clinical Trial Lead with query resolution and aged action item metrics follow up internally.
erforms translations, back-translations or verification of translations of study documentation when needed.
ccurately updates and maintains site level CTMS, as needed.
If needed, assists the project team with CTMS reports at requested intervals to follow-up on pending entries  Prepares and maintains 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, attends non-study related and executive teleconferences and prepares and distributes minutes for meeting attendees within agreed timelines  Prepares and distributes clinical trial supplies to the investigational sites and maintains tracking information  As needed, communicates with sites regarding trial start-up, conduct, and close-out administrative activities.
May participate in feasibility and/or site identification activities.
Provides training and mentoring to new CTAs on Allucent procedures and clinical trial administration, as required.
Obtains quotes from local vendors (printing companies, translators, couriers) and provides information to the Project Specialist (PS) for obtaining approval from PM/CTL prior to placing orders  If needed, provides local support for organization of Investigator Meeting or any other study meeting organized in the country where CTA is located  Performs any other ad hoc administrative tasks not listed above to support team members with clinical trial execution, as required at Country/Site level.
Provides administrative tasks to support Office Managers and Country Managers, as required.
Other responsibilities as needed.