Clinical Trial Associate Ii

hace 4 semanas

Madrid, España Allucent A tiempo completo

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light.

These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

The CTA acts as 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.

eTMF
- 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

ISF/PSF
- 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.

Other Responsibilities
- 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**:

- Life Science related 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 and local language (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 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**
- Comprehensive benefits package
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Leadership and mentoring opportunities
- Internal growth opportunities and career progression
- More task variety
- Financially rewarding internal Employee Referral Program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms

To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes.

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