Clinical Trial Associate II

Allucent

Madrid, Spain

Description

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, 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:

Performs 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;
Performs translations, back-translations or verification of translations of study documentation when needed;
Accurately 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.

Requirements

To be successful you will possess:

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 Documentation Practices Knowledge;
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;
Attention to detail;
Ability to establish and maintain effective working relationships with co-workers and managers;
Knowledge of medical terminology and clinical monitoring process.