Clinical Trial Associate Trainee

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 Trail Associate Trainee (CTA Trainee) based in Madrid to join our A-team (on-site). As a CTA Trainee at Allucent, you act as the primary administrative support to Allucent clinical study teams at Country/Site level, support Clinical Trial Operations and Sponsors, and ensure that the clinical trial is conducted in accordance with regulatory and ethical laws. This is a 6-month program that may have permanent employment at the end of the 6 months.

**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.
- 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.
- Accurately updates and maintains site level CTMS, as needed and assist the project team with CTMS reports at requested intervals to follow-up on pending entries
- Prepares and distributes clinical trial supplies to the investigational sites and maintains tracking information
- May participate in feasibility and/or site identification activities.
- If required, provides local support for organization of Investigator Meeting or any other study meeting organized in the country where CTA is located

**Requirements**:
**To be successful you will possess**:

- Life Science related bachelor’s degree or equivalence (BS/BA) or High School Diploma/Certificate or equivalent combination of education, training and experience
- Experience as CTA Intern/ trainee/CTA I or within a similar role or at least 3 years as a clinical research coordinator.
- Good knowledge of Documentation Practices.
- Good knowledge of Clinical Practices.
- Strong verbal and written communication skills in English and Spanish.
- Computer literacy, proficiency in Microsoft Office.
- Excellent interpersonal and organizational skills.
- Ability to work independently and to effectively prioritize tasks with guidance and oversight.
- Ability to manage several projects.
- Attention to detail.
- Ability to establish and maintain effective working relationships with co-workers and managers.
- Basic knowledge of medical terminology and clinical monitoring process.

**Benefits**

**Benefits of working at Allucent include**:

- Comprehensive benefits package per location
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Opportunity for remote/hybrid* working depending on location
- Leadership and mentoring opportunities
- Participation in our Buddy Program as a new or existing employee
- Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms
- Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
- Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

**Disclaimers**:

- Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

LI-TCW