Clinical Trial Associate II

hace 4 semanas

Madrid, España Allucent A tiempo completo
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 II (CTAII) to join our A-team (hybrid*/remote). As a CTAII 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.

In this role your key tasks will include:

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

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.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

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