Position:
In-House Clinical Research Associate (IHCRA)
About our Client:
Our client is at the vanguard of biotechnological innovation, focusing on cell-based treatment for neurological conditions. They are looking for a driven individual eager to engage with cutting-edge science and contribute significantly to a dynamic research-driven environment.
The Role:
The IHCRA is essential in providing operational support and plays a vital role in the oversight of clinical trial monitoring. They collaborate closely with the study team and external partners to ensure that all monitoring activities meet the highest standards of quality and regulatory compliance.
Job Description:
The IHCRA is tasked with ensuring the strategic and operational aspects of site monitoring are executed efficiently, contributing to the success of clinical trials from conception through completion.
Key Responsibilities:
- Execution of evidence-based site feasibility assessments.
- Assistance in site identification and selection, along with patient retention strategies.
- Management of site feasibility documentation and progress tracking.
- Coordination and oversight of site contract negotiations and ethical committee submissions.
- Development of study start-up materials and facilitation of site training as per protocol.
- Oversight of trial master file (TMF) requirements and audit responses.
Requirements:
- Bachelor’s degree in life sciences or an equivalent healthcare qualification.
- A minimum of two years of relevant industry experience.
- Strong communication skills and proficiency in various project management tools.
- A solid understanding of clinical trial regulations and a detail-oriented approach to study management.
- Ability to travel domestically as required for the role.
Remote Work and Travel: The role allows for flexibility with remote work arrangements while also expecting up to 10% travel to fulfill various study-related duties.
Insights for Candidates:
- Previous experience with clinical trials, especially in cell therapies, is highly regarded.
- Proven track record in supporting clinical trials in collaboration with CROs.
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The Job Description Key Responsibilities:
The IHCRA is tasked with ensuring the strategic and operational aspects of site monitoring are executed efficiently, contributing to the success of clinical trials from conception through completion. Key Responsibilities:
Execution of evidence-based site feasibility assessments. Assistance in site identification and selection, along with patient retention strategies. Management of site feasibility documentation and progress tracking. Coordination and oversight of site contract negotiations and ethical committee submissions. Development of study start-up materials and facilitation of site training as per protocol. Oversight of trial master file (TMF) requirements and audit responses.
Requirements: Bachelor’s degree in life sciences or an equivalent healthcare qualification. A minimum of two years of relevant industry experience. Strong communication skills and proficiency in various project management tools. A solid understanding of clinical trial regulations and a detail-oriented approach to study management. Ability to travel domestically as required for the role.
Working Conditions: The role allows for flexibility with remote work arrangements while also expecting up to 10% travel to fulfill various study-related duties.
PRAGMATIC SEARCH
Pragmatic Insights Previous Companies: Previous experience with clinical trials, especially in cell therapies, is highly regarded.
Proven track record in supporting clinical trials in collaboration with CROs.
Location: This is a remote role but some US travel will be expected
Any specific skill sets: Sponsor-side experience. Central Nervous System (CNS) disorders. Cellular therapy protocols.
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Summary of Pragmatic
Pragmatic Certified is designed to guide you through the minefield of Clinical Operations recruitment. We work with great clients and will help you in securing roles.
Our Solutions Our network, years of experience, and award- winning technology give us unmatched ability to deliver top-notch clinical professionals.
We work with great clients by closely screening out candidates.
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Geographical & Clinical Operational Focus
We are laser-focused on the clinical operations sector. Pragmatic’s expertise spans pharmaceuticals, medical devices, and biotech. Our team provides certified candidates to sponsors, CROs, and research institutes for all phases of global and regional studies.
We have placed over 150 people in Clinical Operations since the start of 2021 across the United States.
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Pragmatic Process
Our 6-phase Pragmatic Certified process ensures that this role will be interviewing in January 2024
KEY MILESTONES
Key Points in this role
Pragmatic’s bespoke technology is designed to reduce process times dramatically. Our award-winning AI and video assessments are designed to help mitigate bias and champion diversity. While this helps level the playing field, it also enables potential superstars to shine early on.
We hope you enjoy this process, which is optimized for mobile to make it easy for you throughout.
You read this job description
Interviews with the client: You will meet with President, General Partner and Senior Directors
We book in an inital call/vc to interview you for this role
We can ensure alignment on all key aspects of the offer to help smooth the transition.
Video Assessment - A 1-way video assessment that takes less than 10 minutes.
We will offer a 12-month success guarantee, so we will stay in touch to help with your onboarding.
TECH USED
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Silver Birch
Gold Honeysuckle
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Refer a Friend
We hope this role is the right one for you. If not, you could help by referring a friend or colleague who could be right for the role. We pay up to $1000 for executive- level placements.
0% upon referal
0% upon placement
100% after 3-months
We offer a 3-month success guarantee, so fees are paid in line with this.
