In-House Clinical Research Associate

Overview

In-House Clinical Research Associate

Be Part of One Team, One Purpose.

At Emmes Group , we're shaping the future of clinical research- where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence , we've led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.

Through our two business units- Emmes, a full-service CRO , and Veridix AI, our technology, data, and analytical solutions -we are modernizing clinical trials and accelerating the development of life-changing therapies.

We believe that every clinical breakthrough starts with people -people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation , ensuring that every challenge is met with perseverance and accountability.

The In-House Clinical Research Associate (CRA) is responsible for assisting with operational activities supporting the site management and monitoring of clinical studies/trials, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and all applicable regulatory requirements. The In-House CRA may also be referred to as a Clinical Trial Associate on some contracts. Responsibilities

• Under the supervision of the project site management staff oversight lead i.e., Clinical Trial Manager, Lead CRA, Clinical Project Manager, etc.
• Possesses basic knowledge of the study protocol, site monitoring plan, and study manuals to triage questions or requests from site staff e.g., enrollment updates, questions, missing documentation, meeting arrangements, etc.
• Knowledge of Good Clinical Practices and country regulatory requirements.
• Collects, reviews, maintains, and tracks required essential documents. Review includes assessment of completeness, accuracy, and compliance with good documentation practices and regulatory and local requirements.
• Upload essential documents into the trial master file.
• Communicates and coordinates effectively with internal project staff members and site staff.
• Assists project teams with trial progress tracking by updating the Clinical Trial Management System and other software tools.
• May assist in audit preparation activities as needed.
• May assist the CRA in Issue and Action Item AI resolution post visit and assists with tracking AIs to completion.
• Tracks site training
• May assist with feasibility and site activation processes in collaboration with clinical operations counterparts.
• May assist in preparing study documents.
• May assist with ordering clinical trial supplies from vendors such as laboratories and Investigational Product depots.
• May track site recruitment efforts and collect review site screening logs.
• May assist with the review of the database to assess data currency and may assist site teams with resolving data queries discrepancies.
• May assist on site CRA in the conduct of remote and or on site monitoring visits such as site initiation visits, interim routine monitoring visits and closeout visits
• Performs other duties as assigned
• Complies with all policies and standards

Qualifications

• Bachelor's Degree Scientific discipline Required
• less than 1 year Previous clinical research experience preferred (as a CTA, in-house CRA, study coordinator, etc.) Preferred
• Proficient with MS Office Suite High
• Good computer and organizational skills High
• High attention to detail required High
• Ability to work on varying projects and exercise critical thinking High
• self starter and a team player who can work cross functionally with heavy oversight High
• Proficient in organizational, interpersonal, and communication skills both oral and written High
• Demonstrated problem solving skills, self motivated, and adaptable to a dynamic environment High
• Knowledgeable in prioritization, problem solving, organization, critical thinking, decision making, time management, and planning activities High
• Ability to collaborate with internal and external colleagues and work well in a team oriented setting High

If you're looking for a career where your work advances global health and where scientific excellence meets real-world impact , join us and be part of something bigger. One Team, One Purpose.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

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The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

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