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Clinical Trial Associate

Are you passionate about supporting the successful execution of clinical trials and ensuring the development of life-changing therapies? At WEP Clinical, we are dedicated to helping patients gain early access to innovative treatments. We offer a collaborative environment where your contributions are valued, and we provide opportunities for both professional growth and personal fulfillment. Join our team as a Clinical Trial Associate and play a key role in advancing medical research while making a real impact on patients' lives!



Role Objectives:

The Clinical Trial Associate(CTA) at WEP Clinical plays a key role in the effective execution of clinical trials by managing essential documentation, coordinating site activities, and adherence to regulatory standards. This role is responsible for supporting site start-up activities, maintaining the electronic Trial Master File (eTMF)and providing dedicated support to site personnel and project teams throughout the trial lifecycle to achieve objectives for clinical research projects, programs, studies, and trials. 


The Ideal Candidate:
  • Team Player
  • Detail Oriented
  • Problem Solver
  • Adaptable


What You'll Do:
  • Collaborate with the project team to develop site initiation timelines and ensure adherence to milestones.
  • Prepare and manage site start-up documentation, including contracts, informed consent forms, and regulatory submissions.
  • Coordinate with contracts and budget teams to ensure timely execution of site agreements.
  • Monitor the progress of regulatory submissions and site contracts to prevent delays in site activation.
  • Verify that site personnel are trained on trial protocols, safety procedures, and reporting requirements before patient enrollment.
  • Ensure site resources (staff, facilities, equipment) are available and confirm site readiness through checklists.
  • Participate in kick-off meetings with site personnel to align on expectations, timelines, and responsibilities.
  • Troubleshoot activation issues, escalating to site or project managers as needed.
  • Help ensure the proper set-up of study supplies and investigational products at the site.
  • Maintain and update the electronic Trial Master File (eTMF), ensuring it is inspection-ready at all times.
  • Assist with regulatory document preparation, review, and submission.
  • Support CRAs and Project Managers in coordinating site communication, meetings, and study supplies shipment, and assist in site close-out.


What You'll Need:
  • A Bachelor's Degree is preferred, particularly in a health or science-related field. 
  • Certification in clinical research (e.g., SOCRA, ACRP) is a plus, but not required  
  • 0-4 years’ experience in site management, clinical research, or equivalent combination of education, experience, and expertise  
  • Knowledge of clinical trial processes, regulatory requirements, and Good Clinical Practice (GCP) 
  • Computer literacy and proficient in Microsoft Office  
  • Effective verbal and written communication skills  
  • Ability to handle confidential information with complete discretion  
  • Strong organizational skills and attention to detail  


What We Offer:

Medical, dental, and vision insurance, FSA, HSA

Voluntary short-term and long-term disability insurance

Voluntary life insurance

401K safe harbor plan and company match

Paid vacation, holiday, and sick time

Paid maternity & paternity leave


What sets us apart:

WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.


We're Committed to Our Team:

WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.


We're Committed to DEI:

At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.


Our services include:

Expanded Access Programs (EAPs)

Named Patient Programs (NPPs)

Clinical Trial Supplies (Comparator & Ancillaries)

Wren Nursing (Clinical Trial Home Nursing & Clinical Education)

Hospital Supply of Unlicensed Medicines


WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.


WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.


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Average salary estimate

$62500 / YEARLY (est.)
min
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$50000K
$75000K

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What You Should Know About Clinical Trial Associate, WEP Clinical

Are you ready to jumpstart your career in clinical research? At WEP Clinical, we're looking for a Clinical Trial Associate to join our remote team in Canada! As a Clinical Trial Associate, you'll play a fundamental role in supporting the execution of clinical trials aimed at delivering life-changing therapies to patients. You will work alongside a dynamic project team, developing timelines and ensuring that everything runs smoothly—from site initiation to monitoring essential documentation. Your attention to detail will be crucial as you'll be responsible for verifying that all site personnel are adequately trained on trial protocols and ensuring that our electronic Trial Master File (eTMF) is always inspection-ready. Plus, you'll get the chance to address any activation issues and collaborate with multiple teams to ensure the timely execution of site agreements. We’re seeking a detail-oriented problem solver who thrives in a collaborative environment. The ideal candidate has a Bachelor’s degree—preferably in a health or science-related field—and should be proficient in Microsoft Office. While certification in clinical research is a plus, we value your experience in site management and clinical research even more! When you join WEP Clinical, you become a part of an organization that’s committed to personal and professional growth. Here, your contributions are not just acknowledged; they're celebrated. Jump into a fulfilling career where you can truly make a difference in patients' lives!

Frequently Asked Questions (FAQs) for Clinical Trial Associate Role at WEP Clinical
What are the main responsibilities of the Clinical Trial Associate at WEP Clinical?

As a Clinical Trial Associate at WEP Clinical, your primary responsibilities include managing essential documentation, coordinating site activities, and adhering to regulatory standards throughout the clinical trial lifecycle. This involves preparing site start-up documents, ensuring site readiness, and playing a vital role in training site personnel on trial protocols.

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What qualifications do I need to become a Clinical Trial Associate at WEP Clinical?

To qualify for the Clinical Trial Associate position at WEP Clinical, a Bachelor's Degree in a health or science-related field is preferred. While certification in clinical research such as SOCRA or ACRP is beneficial, it is not mandatory. Relevant experience in site management or clinical research combined with strong organizational and communication skills will also be an asset.

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What does the training process look like for new Clinical Trial Associates at WEP Clinical?

New Clinical Trial Associates at WEP Clinical undergo comprehensive training that includes familiarization with clinical trial processes, regulatory requirements, and Good Clinical Practice (GCP) guidelines. You'll work closely with experienced team members who will guide you through the tools and documentation needed for successful site management.

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How does WEP Clinical support its Clinical Trial Associates during a trial?

WEP Clinical provides dedicated support to its Clinical Trial Associates by ensuring access to resources and assistance during all phases of a trial. This includes collaborating with project teams, coordinating communication with sites, and ensuring that study supplies are shipped effectively, enabling you to focus on driving the success of clinical trials.

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What opportunities for advancement are available for Clinical Trial Associates at WEP Clinical?

At WEP Clinical, we prioritize the professional growth of our employees. As a Clinical Trial Associate, you'll have opportunities to advance your career through continuous learning, mentorship, and the chance to take on more responsibilities within the organization, paving the way for future roles in clinical project management or specialized research areas.

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Common Interview Questions for Clinical Trial Associate
What makes you interested in the Clinical Trial Associate position at WEP Clinical?

When answering this question, focus on your motivation for working in clinical research and how you align with WEP Clinical's mission to provide early access to therapies. Highlight your eagerness to support innovative treatments and contribute positively to patient care.

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Can you describe a time when you managed multiple tasks or deadlines?

Utilize the STAR method to discuss how you successfully prioritized and managed competing deadlines. Ensure to highlight how your organizational skills helped you meet all your commitments, particularly in relation to clinical trial activities.

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How do you approach problem-solving in a clinical trial environment?

Share a specific method or strategy you use to approach problem-solving. Emphasize your analytical skills and ability to collaborate with teams to troubleshoot and resolve issues effectively, showcasing your adaptability in a clinical trial setting.

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What are Good Clinical Practice (GCP) guidelines, and why are they important?

Explain briefly that Good Clinical Practice (GCP) guidelines are international quality standards that govern clinical trial conduct. Express your understanding of their importance in ensuring the integrity of data, patient safety, and compliance with regulatory standards.

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How would you handle a situation where a site is not meeting its recruitment targets?

Discuss your proactive approach to communication and problem-solving. Outline how you would assess the situation, engage with site personnel to identify barriers, and suggest adjustments to recruitment strategies to help meet targets.

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What experience do you have with managing regulatory documentation?

Share any relevant experience you have handling regulatory documents, emphasizing your attention to detail and familiarity with processes like submissions and compliance, which are essential for the Clinical Trial Associate role.

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How do you ensure that team members are trained on trial protocols?

Discuss your approach to onboarding and training, perhaps mentioning strategies you implement to verify comprehension and retention of information. Highlight the importance of proper training for successful trial execution.

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Describe how you maintain an inspection-ready electronic Trial Master File (eTMF).

Elaborate on the systematic approach you take to organize and regularly update eTMF contents, ensuring all documentation is readily available and compliant with regulatory standards, thus making it always inspection-ready.

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How do you prioritize your workload in a fast-paced clinical trial environment?

Highlight your organizational skills and tools you use to prioritize tasks effectively. Discuss how you manage deadlines without compromising quality, which is especially vital in the context of clinical trials.

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What is your understanding of the role of a Clinical Trial Associate in supporting CRAs and Project Managers?

Explain your recognition of the CTA's supporting role, focusing on collaboration and how CTAs help streamline processes and enhance efficiency for Clinical Research Associates (CRAs) and Project Managers throughout the study lifecycle.

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WEP Clinical is a pharmaceutical services company focused on providing patients and health institutions access to much-needed drugs through Expanded Access Programs (EAP) and Named Patient Programs (NPP). WEP Clinical was founded in 2008 and is he...

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Full-time, remote
DATE POSTED
January 12, 2025

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