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Clinical Research Assistant

Piper Clinical Solutions is seeking a Clinical Research Assistant in the Bethesda, MD area to support a well-established clinical research organization (CRO) focused on providing biopharmaceutical development support, health information services, and health & environment assessments to commercial and government clients.Responsibilities of the Clinical Research Assistant include:• Assist in overall project support to various clinical research studies, with a specific focus in medical writing• Revise Standard Operating Procedures (SOPs) for ongoing clinical research studies• Assist various departments in Regulatory, Project Management, Data Management, and Clinical Operations• Abstract protocol information into databases in support of clinical trials• Respond to queries regarding clinical research studies associated with protocols and abstractionsRequirements of the Clinical Research Assistant include:• Experience with IRB/GCP regulations• Bachelor’s Degree in Science related field (Master’s preferred)Compensation for the Clinical Research Assistant include:• Salary Range: $45,000 - $55,000 **depending on experience**• Full Benefits: Full Benefits through Cigna (Health, Vision & Dental Insurance), 401KKeywords:CRO, Clinical research organization, clinical trials, pharmaceutical, biotechnology, biotech, gcp, good clinical practices, qms, quality management system, quality management plans, cqms, sop, standard operating procedures, protocol, quality assurance, qa, capa, MPH, master of science, MS, physiology, pharmacology, biotechnology, pharmaceutical, clinical research, epidemiology, biostats, medical writer, clinical research assistant, clinical research associate, CRA, CTA, clinical trial assistant, research associate, research assistant, research, REDCap, medidata, RAVE, EDC, electronic data capture, CTMS, clinical trial management system, IRB, institutional review board, clinical trials, publication, research project, medical scribe, medical assistant, meeting minutes, SOP, standard operating procedure, science writing, science writer
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What You Should Know About Clinical Research Assistant, Piper Companies

Looking for an exciting opportunity in the heart of Bethesda, MD? Piper Clinical Solutions is on the hunt for a Clinical Research Assistant to join a dynamic clinical research organization (CRO) that specializes in biopharmaceutical development and health assessments. As a Clinical Research Assistant, you'll play a vital role in supporting various clinical studies, with a keen focus on medical writing. You won’t just be crunching numbers; you’ll collaborate with multiple departments, including regulatory affairs and project management, to ensure our studies run smoothly. Your responsibilities will involve revising Standard Operating Procedures (SOPs), abstracting crucial protocol information into databases, and being the point person for any queries that arise related to clinical research protocols. This position is ideal for someone with a Bachelor’s Degree in a science-related field—preferably with a Master’s—and experience with IRB and GCP regulations. On top of a competitive salary range of $45,000 - $55,000, depending on your experience, you'll enjoy comprehensive benefits through Cigna, covering health, vision, and dental insurance, plus a 401K plan. Join us in making a difference in the world of clinical research!

Frequently Asked Questions (FAQs) for Clinical Research Assistant Role at Piper Companies
What are the responsibilities of a Clinical Research Assistant at Piper Clinical Solutions?

As a Clinical Research Assistant at Piper Clinical Solutions, your main responsibilities will include supporting various clinical research studies, particularly through medical writing, revising SOPs, and working closely with departments like Regulatory, Project Management, and Clinical Operations. You'll also be involved in abstracting protocol information into databases to support ongoing clinical trials and responding to queries related to these studies.

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What qualifications are needed for the Clinical Research Assistant position at Piper Clinical Solutions?

To qualify for the Clinical Research Assistant position at Piper Clinical Solutions, candidates should possess a Bachelor’s Degree in a science-related field, such as biology or pharmacology, with a Master’s preferred. Additionally, experience with IRB and GCP regulations is essential to ensure compliance with clinical study standards.

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What is the salary range for the Clinical Research Assistant role at Piper Clinical Solutions?

The salary range for the Clinical Research Assistant role at Piper Clinical Solutions is between $45,000 and $55,000, depending on your experience level. This competitive salary is complemented by a robust benefits package to support your health and financial well-being.

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Is prior clinical research experience required for the Clinical Research Assistant position?

While prior clinical research experience is not strictly required for the Clinical Research Assistant position at Piper Clinical Solutions, having a background in clinical trials can be advantageous. Familiarity with medical writing and SOPs will also enhance your prospects for this role.

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What benefits are offered to Clinical Research Assistants at Piper Clinical Solutions?

Piper Clinical Solutions offers a comprehensive benefits package for Clinical Research Assistants that includes health, vision, and dental insurance through Cigna, alongside a 401K plan. These benefits ensure that our employees feel secure and supported in their personal and professional lives.

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Common Interview Questions for Clinical Research Assistant
Can you describe your experience with IRB and GCP regulations?

When answering this question, highlight any specific training or certifications you've received related to IRB and GCP regulations. Discuss particular challenges you've faced in adhering to these standards and how you overcame them, demonstrating your understanding of their importance in clinical research.

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What is your approach to medical writing in clinical research?

Discuss your understanding of medical writing and its critical role in clinical trials. Provide examples of documentation you've produced, how you ensure accuracy and clarity, and your methods for revising written material based on feedback from stakeholders.

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How do you handle data accuracy and compliance in clinical trials?

Emphasize your attention to detail and organizational skills when answering this question. Explain any systems or processes you use to maintain accuracy, including how you check and double-check data entries and ensure compliance with SOPs.

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What steps do you take to support project teams effectively?

Illustrate your collaborative spirit by discussing how you communicate with project teams, manage timelines, and handle any potential roadblocks. Being proactive and supporting team members shows your commitment to ensuring project success.

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How would you respond to queries regarding clinical research protocols?

Showcase your knowledge and resourcefulness in dealing with such queries. Mention your approach to gathering the necessary information before responding and point out the importance of clear communication with both internal and external stakeholders.

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What experience do you have in abstracting information for databases?

When addressing this question, mention any specific tools or software you are accustomed to using for data abstraction. If possible, provide examples of how you've ensured the accuracy and integrity of the information you abstract.

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Why do you want to work as a Clinical Research Assistant at Piper Clinical Solutions?

Be sincere and specific about your interests in clinical research and why Piper Clinical Solutions stands out to you. Highlight aspects of the company culture, mission, or projects they are involved with that resonate with you.

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Can you give an example of how you managed a difficult situation in a clinical research project?

Provide a specific situation where you faced a challenge in a clinical study, explaining the context, your thought process, and how you resolved the issue. This answer showcases your problem-solving skills and adaptability.

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What tools or software are you familiar with that are used in clinical research?

List any relevant software such as electronic data capture systems (EDC), clinical trial management systems (CTMS), or data analysis tools you have experience with. Explain how you’ve used these tools in your previous roles.

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How do you ensure you stay updated on current regulations and best practices in clinical research?

Discuss your commitment to continuous learning in the field of clinical research. You can mention attending workshops, reading industry publications, or participating in professional organizations to ensure you are aware of the latest regulations and best practices.

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December 11, 2024

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