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Clinical Trial Associate II/Senior CTA (Serbia)

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 Trial Associate II/Senior CTA based in Belgrade to join our A-team (on-site/hybrid*). As a CTA 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:

  • 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

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 a CTA I/II 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 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.” #LI-JC1

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Average salary estimate

$60000 / YEARLY (est.)
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$50000K
$70000K

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What You Should Know About Clinical Trial Associate II/Senior CTA (Serbia), Allucent

At Allucent™, we strive to empower small to medium biopharmaceutical companies in navigating the intricate landscape of clinical trials, aiming to introduce life-transforming therapies to patients around the world. We’re currently on the lookout for a Clinical Trial Associate II/Senior CTA who is ready to join our dynamic team in Belgrade. This role can be performed on-site or in a hybrid setup, bringing that perfect blend of flexibility and collaboration! As a CTA at Allucent, you’ll be the backbone of our clinical study teams at the country and site level. Your daily tasks will involve performing quality checks of critical documents before they hit the eTMF, ensuring everything is not just complete but also meets our high standards. You’ll take the lead on submitting key documents and resolving any issues with rejections, working closely with the TMF Lead to keep our operations running smoothly. From maintaining public folders to preparing investigator site files and supporting CRAs, you'll be the go-to person for ensuring our documentation is inspection-ready. We put a premium on attention to detail and organizational skills, so your ability to prioritize tasks and manage multiple projects simultaneously will shine in this role. Plus, if you have a bachelor’s degree in a life science-related field or equivalent experience and are fluent in English and Spanish, you will fit right in with our team. At Allucent, we value your professional growth with various training programs and a supportive, flexible work environment. Join us and play a pivotal role in the clinical trial process!

Frequently Asked Questions (FAQs) for Clinical Trial Associate II/Senior CTA (Serbia) Role at Allucent
What are the key responsibilities of a Clinical Trial Associate II/Senior CTA at Allucent?

As a Clinical Trial Associate II/Senior CTA at Allucent, you will perform critical tasks such as quality checking documents, submitting country and site level files to the eTMF, and assisting the clinical study teams with essential documentation and tracking tasks. You’ll also be involved in preparing investigator site files and maintaining up-to-date records within the CTMS, ensuring a high standard of organization and compliance throughout the clinical trial.

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What qualifications are necessary for the Clinical Trial Associate II/Senior CTA role at Allucent?

To excel in the Clinical Trial Associate II/Senior CTA role at Allucent, candidates should have a life sciences bachelor’s degree or equivalent experience, along with at least three years of experience as a clinical research coordinator or a lower CTA position. A strong understanding of clinical practices, documentation practices, and basic medical terminology are essential. Strong communication skills in both English and Spanish are also required for effective collaboration within our teams.

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What does the hybrid working policy at Allucent look like for the Clinical Trial Associate II/Senior CTA position?

The hybrid working policy at Allucent encourages a balanced work environment, where Clinical Trial Associates II/Senior CTAs can work from the office and home. The policy typically prescribes two days in the office each week for employees who are within reasonable distance from one of our global offices, while also promoting flexibility based on individual needs.

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How does Allucent support the professional development of its Clinical Trial Associates?

At Allucent, we believe in investing in our employees' growth. Clinical Trial Associates II/Senior CTAs benefit from a departmental study and training budget that supports their professional development. Additionally, there are opportunities access to online technical and soft skills training through platforms like GoodHabitz, fostering continuous learning and career advancement in the ever-evolving field of clinical research.

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What skills are emphasized for a Clinical Trial Associate II/Senior CTA at Allucent?

Successful Clinical Trial Associates II/Senior CTAs at Allucent possess excellent organizational and interpersonal skills, enhanced attention to detail, and the ability to manage multiple projects effectively. Proficiency in Microsoft Office and communication skills in both English and Spanish are also emphasized, enabling clear and efficient collaboration with team members and stakeholders.

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Common Interview Questions for Clinical Trial Associate II/Senior CTA (Serbia)
Can you explain your experience with document quality checks in clinical trials?

In your response, highlight specific examples from your previous roles where you performed document quality checks, detailing the types of documents you managed and your process for ensuring accuracy and compliance. Discuss how your attention to detail contributed to successful trial outcomes.

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How do you prioritize your tasks when managing multiple projects as a Clinical Trial Associate II?

Discuss a structured approach, like creating a task list or using project management tools, to prioritize your responsibilities. Give examples of how you’ve balanced competing deadlines effectively in your previous roles to meet the needs of clinical study teams.

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What challenges have you faced when preparing investigator site files, and how did you overcome them?

Share a specific challenge, such as facing tight deadlines or discrepancies in documents, and describe how you effectively resolved the issue. Emphasize your problem-solving skills and commitment to ensuring accurate and compliant documentation.

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Describe your experience with regulatory and ethical standards in clinical trials.

Talk about your understanding of the regulatory environment and ethical considerations that guide clinical trials. Provide instances where you ensured compliance with these standards in your work as a Clinical Trial Associate or Coordinator.

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What software tools have you used for document management in clinical trials?

List the software and tools you are familiar with, such as eTMF systems or CTMS, and provide examples of how you utilized them in previous roles. Emphasize your ability to quickly adapt to new technologies as required.

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How do you handle communication with clinical trial teams and stakeholders?

Detail your communication style and provide examples of how you maintain transparency with team members, ensuring everyone stays informed. Mention any tools you’ve used to streamline communication, like project management systems or email updates.

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What steps do you take to ensure inspection readiness of the TMF?

Discuss your approach to maintaining an organized and compliant TMF, including regular updates to key documents and proactive communication with your team. Share your experience in preparing for inspections and addressing any findings.

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How do you support CRAs during site visits?

Provide examples of the types of support you have offered to CRAs, such as helping prepare the necessary documentation and ensuring that all materials are readily available. Discuss how you've contributed to successful site visits through your organizational skills.

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Can you explain how attention to detail impacts your role as a Clinical Trial Associate?

Emphasize the critical nature of attention to detail in clinical trials, using illustrative examples from past experiences where your careful review of documents led to positive outcomes, such as passing audits or avoiding compliance issues.

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What motivates you to work in the clinical research field?

Reflect on your passion for contributing to the development of life-changing therapies and your commitment to ethical practices in clinical research. Share personal anecdotes or experiences that inspire your work in this field.

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Full-time, hybrid
DATE POSTED
March 13, 2025

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