Clinical Trial Associate Trainee

hace 2 semanas

Madrid, Madrid, España Allucent A tiempo completo
About the Role

We are seeking a highly motivated and detail-oriented Clinical Trial Associate Trainee to join our team at Allucent. As a Clinical Trial Associate Trainee, you will play a critical role in supporting our clinical study teams at the country/site level, ensuring the smooth execution of clinical trials in accordance with regulatory and ethical laws.

Key Responsibilities
  • Document Management: Perform quality checks on documents prior to submission to ensure accuracy and completeness.
  • eTMF Submission: Act as a document submitter and submit country and site-level documents to the eTMF Document Inbox, resolving any rejections.
  • QC Resolution: Assist in resolving periodic QC findings for country and site eTMF.
  • Communication: Communicate with the TMF Lead/Project Specialist to follow up on country and site-level eTMF status.
  • EDL Updates: Update the Expected Documents List (EDL) in eTMF for the country and site level.
  • Public Folders: Maintain Public Folders in accordance with the Study Correspondence Management Plan.
  • ISF/PSF Preparation: Prepare and distribute Investigator Site Files (ISFs/eISFs), Pharmacy Site Files (PSFs/ePSFs), or other files needed for Site Initiation Visits (SIVs).
  • QC/Inventory Checklists: Prepare and maintain QC/Inventory Checklists for the ISFs/PSFs to support CRA with preparation for site visits and paperwork after site visits.
  • CTMS Updates: Accurately update and maintain site-level CTMS, as needed, and assist the project team with CTMS reports at requested intervals to follow up on pending entries.
  • Clinical Trial Supplies: Prepare and distribute clinical trial supplies to investigational sites and maintain tracking information.
  • Feasibility and Site Identification: May participate in feasibility and/or site identification activities.
  • Local Support: Provide local support for organization of Investigator Meetings or any other study meetings organized in the country where the CTA is located.
Requirements
  • Education: Life Science-related bachelor's degree or equivalence (BS/BA) or High School Diploma/Certificate or equivalent combination of education, training, and experience.
  • Experience: Experience as a CTA Intern/Trainee/CTA I or within a similar role or at least 3 years as a clinical research coordinator.
  • Knowledge: Good knowledge of documentation practices and clinical practices.
  • Language: Strong verbal and written communication skills in English and Spanish.
  • Computer Skills: Computer literacy, proficiency in Microsoft Office.
  • Interpersonal Skills: Excellent interpersonal and organizational skills.
  • Ability to Work Independently: Ability to work independently and to effectively prioritize tasks with guidance and oversight.
  • Project Management: Ability to manage several projects.
  • Attention to Detail: Attention to detail.
  • Relationship Building: Ability to establish and maintain effective working relationships with co-workers and managers.
  • Medical Terminology: Basic knowledge of medical terminology and clinical monitoring process.
Benefits
  • Comprehensive Benefits Package: Comprehensive benefits package per location.
  • Competitive Salaries: Competitive salaries per location.
  • Departmental Study/Training Budget: Departmental Study/Training Budget for furthering professional development.
  • Flexible Working Hours: Flexible working hours (within reason).
  • Remote/Hybrid Working: Opportunity for remote/hybrid* working depending on location.
  • Leadership and Mentoring Opportunities: Leadership and mentoring opportunities.
  • Buddy Program: Participation in our Buddy Program as a new or existing employee.
  • Internal Growth Opportunities: Internal growth opportunities and career progression.
  • Employee Referral Program: Financially rewarding internal employee referral program.
  • Soft-Skills and Technical Training: Access to online soft-skills and technical training via GoodHabitz and internal platforms.
  • Spot Bonus Award Program: Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects.
  • Loyalty Award Program: Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees.

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