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Clinical Trial Coordinator II

hace 2 meses

Madrid, Madrid, España Allucent A tiempo completo

At Allucent, we are committed to assisting small to medium-sized biopharmaceutical organizations in effectively navigating the intricate landscape of clinical trials, ultimately delivering transformative therapies to patients worldwide.

We are seeking a Clinical Trial Coordinator II (CTA II) to become a vital member of our dynamic team (hybrid). In this role, you will provide essential administrative support to Allucent's clinical study teams at the Country/Site level, facilitating Clinical Trial Operations and Sponsors. Your efforts will ensure that clinical trials are executed in compliance with international regulations, local laws, ethical standards, and guidelines for Good Clinical Practice and Standard Operating Procedures. You will assist the study team with the daily management of international clinical studies under the mentorship of an experienced team member at the Country/Site Level.

Your key responsibilities will include:

  • Conducting quality checks on documents prior to eTMF submission to guarantee completeness and accuracy for filing.
  • Acting as Document Submitter post-quality check, submitting country and site-level documents to the eTMF Document Inbox, and resolving any rejections.
  • Assisting in the resolution of periodic QC findings for country and site eTMF.
  • Maintaining study wet-ink documents temporarily in the local office and preparing them for shipment to the client at the study's conclusion, if applicable.
  • Communicating with the TMF Lead / Project Specialist to follow up on the status of country and site-level eTMF.
  • Updating the Expected Documents List (EDL) in eTMF for the country and site level.
  • Managing Public Folders in alignment with the Study Correspondence Management Plan.
  • Preparing and distributing Investigator Site Files (ISFs/eISFs), Pharmacy Site Files (PSFs/ePSFs), or other necessary files for Site Initiation Visits (SIVs).
  • Creating and maintaining QC/Inventory Checklists for ISFs/PSFs to assist CRAs in preparing for site visits and managing paperwork post-visits.
  • Supporting CRAs with the reconciliation of ISF/PSF versus TMF and collaborating with the TMF Specialist and Project Specialist/TMF Lead to ensure TMF inspection readiness.
  • Assisting CRAs/Clinical Trial Leads with query resolution and tracking aged action item metrics internally.
  • Performing translations, back-translations, or verification of translations of study documentation as required.
  • Accurately updating and maintaining site-level CTMS as necessary.
  • Providing assistance to the project team with CTMS reports at requested intervals to follow up on pending entries.
  • Preparing and maintaining study trackers related to country and sites as needed.
  • Participating in project-specific teleconferences and preparing and delivering minutes when demonstrating a high level of written and spoken English.
  • Attending non-study-related and executive teleconferences as needed and preparing and distributing minutes for meeting attendees within agreed timelines.
  • Coordinating the distribution of clinical trial supplies to investigational sites and maintaining tracking information.
  • Communicating with sites regarding trial start-up, conduct, and close-out administrative activities as needed.
  • Engaging in feasibility and/or site identification activities as required.
  • Providing training and mentoring to new CTAs on Allucent procedures and clinical trial administration as necessary.
  • Obtaining quotes from local vendors (printing companies, translators, couriers) and supplying information to the Project Specialist for obtaining approval from PM/CTL prior to placing orders.
  • Offering local support for organizing Investigator Meetings or any other study meetings in the country where the CTA is located as needed.
  • Performing any other ad hoc administrative tasks not listed above to support team members with clinical trial execution at the Country/Site level.
  • Providing administrative support to Office Managers and Country Managers as required.
  • Other responsibilities as needed.

Requirements

To excel in this role, you will need:

  • A High School Diploma/Certificate or an equivalent combination of education, training, and experience; a bachelor's degree or equivalent (BS/BA) is preferred.
  • A minimum of 2 years of experience as a CTA I or in a similar role, or at least 3 years as a clinical research coordinator.
  • Knowledge of Good Documentation Practices.
  • Understanding of Good Clinical Practices.
  • Fluency in English (both spoken and written).
  • Strong verbal and written communication skills.
  • Proficiency in Microsoft Office and computer literacy.
  • Excellent interpersonal and organizational skills.
  • The ability to work independently and effectively prioritize tasks with some guidance and oversight.
  • Capability to manage multiple projects simultaneously.
  • Attention to detail.
  • The ability to establish and maintain effective working relationships with colleagues and supervisors.
  • Familiarity with medical terminology and the clinical monitoring process.

Benefits

Working at Allucent offers:

  • A comprehensive benefits package tailored to your location.
  • Competitive salaries based on your location.
  • A departmental study/training budget to enhance your professional development.
  • Flexible working hours (within reason).
  • Opportunities for remote/hybrid working depending on your location.
  • Leadership and mentoring opportunities.
  • Participation in our Buddy Program for new or existing employees.
  • Internal growth opportunities and career progression.
  • A financially rewarding internal employee referral program.
  • Access to online soft-skills and technical training through GoodHabitz and internal platforms.
  • Eligibility for our Spot Bonus Award Program in recognition of exceptional project contributions.
  • Eligibility for our Loyalty Award Program to honor long-standing employees' commitment.

Disclaimers:

*Our hybrid work policy promotes a dynamic work environment, recommending 2 days in the office per week for employees within a reasonable distance from one of our locations.

The Allucent Talent Acquisition team oversees 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 collaboration requests regarding our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to consider those individuals for future employment or provide remuneration to any third-party recruitment agency. Candidates should not be submitted directly to our hiring managers, employees, or human resources.

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