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Clinical Research Coordinator

Overview

At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. We’re an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant engagement Founded in 2018, our company operates 20+ clinical trial sites in the US and Canada with rapid plans for expansion.  

 

 

The Role

 

Headlands Research in Plymouth is looking for a Clinical Research Coordinator to manage clinical research protocols. This individual will work directly with the investigators, and other research staff to ensure protocol visits are being conducted according to ICH GCP guidelines.

 

 

Responsibilities

  • Comprehend study design of each protocol that is assigned
  • Perform procedures in compliance with the study protocol
  • Recruit and screen study subjects according to specific protocol requirements
  • Collect and record study data in source documents via electronic system (CRIO)
  • Manage study related activities
  • Adherence to protocol requirements
  • Review laboratory data
  • Assess and document compliance
  • Manage investigational product
  • Assess, record, and report Adverse Events as outlined in the protocol
  • Manage/train ancillary staff

 

Qualifications

Education:

  • Experience and training in conducting clinical trials with knowledge of ICH GCP

OR

  • Two years of college in a health-related program or LPN

OR

  • Bachelor’s degree in a health or scientific related program
  • A thorough understanding of regulatory requirements
  • Excellent interpersonal and communication skills: Able to interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects, and referral sources.
  • Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens
  • Experience with CRIO (Clinical Trial Management System) is a plus
  • Experience with administering vaccines is a plus

Average salary estimate

$70000 / YEARLY (est.)
min
max
$60000K
$80000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Clinical Research Coordinator, Headlands Research

At Headlands Research, located in the heart of Plymouth, we're revamping clinical trial delivery with innovation and community engagement at the forefront. As our dedicated Clinical Research Coordinator, you will be the driving force behind managing clinical research protocols that contribute significantly to medical advancements. We pride ourselves on being a close-knit family of clinical trial sites that leverage cutting-edge technology and high-touch support services. In this role, you’ll collaborate directly with investigators and fellow research staff, ensuring that all protocol visits align with ICH GCP guidelines. Your days will be filled with understanding study designs, recruiting and screening participants, managing data collection digitally via our CRIO system, and ensuring adherence to regulatory requirements. Your responsibilities will also include reviewing laboratory data, assessing protocol compliance, managing investigational products, and training ancillary staff. If you have a foundation in clinical trials or a health-related academic background, strong communication skills, and a knack for meticulous detail, this might be your perfect fit. Join us in this essential role and help shape the future of clinical research at Headlands Research!

Frequently Asked Questions (FAQs) for Clinical Research Coordinator Role at Headlands Research
What are the primary responsibilities of a Clinical Research Coordinator at Headlands Research?

The Clinical Research Coordinator at Headlands Research is responsible for managing clinical research protocols, ensuring that all protocol visits comply with ICH GCP guidelines, recruiting and screening study subjects, collecting and recording data in our electronic system CRIO, and leading study-related activities to stay compliant with regulatory requirements.

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What qualifications are needed to become a Clinical Research Coordinator at Headlands Research?

To qualify for the Clinical Research Coordinator position at Headlands Research, candidates should have experience in conducting clinical trials, or possess a health-related degree or training such as an LPN. A thorough understanding of regulatory requirements and excellent communication skills are essential, along with any relevant experience in clinical assessments and possibly CRIO management.

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How does Headlands Research support Clinical Research Coordinators in their role?

Headlands Research supports Clinical Research Coordinators by offering an innovative work environment equipped with advanced technology and comprehensive training programs. This structure encourages professional growth and effective management of clinical trial protocols while fostering a collaborative atmosphere among staff.

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What is the work environment like for a Clinical Research Coordinator at Headlands Research?

The work environment for a Clinical Research Coordinator at Headlands Research is dynamic and collaborative. Situated in Plymouth, the team comprises dedicated professionals focused on enhancing clinical trial delivery using cutting-edge technologies and high-quality support, all while maintaining strong community engagement.

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What experience is beneficial for a Clinical Research Coordinator role at Headlands Research?

Ideal candidates for the Clinical Research Coordinator role at Headlands Research should have prior experience in conducting clinical trials, performing clinical assessments, and managing clinical trial management systems like CRIO. Experience in recruiting study participants and administering vaccines is also highly valued.

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Common Interview Questions for Clinical Research Coordinator
Can you walk us through your experience with clinical trials?

Be sure to highlight specific trials you've worked on, detailing your responsibilities and how you ensured adherence to protocols. Providing examples of challenges you faced and how you overcame them can illustrate your problem-solving abilities and depth of experience.

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How do you ensure compliance with ICH GCP guidelines?

Discuss your familiarity with ICH GCP guidelines and share the methods you use to ensure compliance, such as regular training, meticulous record-keeping, and ongoing communication with the research team to adhere to all protocol requirements.

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What strategies do you use for recruiting study participants?

You might discuss various recruitment strategies you've employed such as outreach programs, building relationships with community organizations, and leveraging social media. Provide examples of successful campaigns you've used to engage and recruit participants effectively.

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How do you manage data collection and ensure accuracy?

Explain your experience with data collection systems like CRIO and your systematic approach to ensuring data accuracy, including double-checking entries, conducting regular audits, and maintaining comprehensive source documents to support the study's integrity.

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Describe your experience with adverse event reporting.

Discuss your understanding of adverse event reporting protocols and provide specific examples of how you’ve identified, assessed, and reported adverse events in past trials. Emphasizing your attention to detail and compliance with regulatory standards will demonstrate your competency.

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What do you consider the most challenging aspect of being a Clinical Research Coordinator?

Your answer could reflect on time management in juggling multiple tasks, managing participant enrollment, or handling unexpected protocol changes. Discuss strategies you've implemented to overcome these challenges and maintain high quality in your work.

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How do you train ancillary staff in a clinical trial setting?

Share an overview of the training methods you utilize, from formal presentations to hands-on training sessions. Emphasize the importance of clear communication and ongoing support to ensure that all staff members understand their roles and responsibilities.

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What measures do you take to maintain participant confidentiality?

Outline your understanding of confidentiality protocols and measures taken to safeguard sensitive participant information, such as securing records, data encryption, and adherence to HIPAA regulations to protect participant privacy.

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Why do you want to work with Headlands Research as a Clinical Research Coordinator?

Express your enthusiasm for the mission of Headlands Research, emphasizing the company’s values in enhancing clinical trial delivery and community engagement. Highlight how these align with your own professional goals and passion for clinical research.

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How do you handle stressful situations that arise in clinical trials?

Share your approach to stress management, whether through prioritizing tasks, maintaining open communication with your team, or developing contingency plans to address potential issues proactively.

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