Government Sector Sr. In-House CRA

Emmes Group; Oregon; Hybrid; USD 70,000 - 95,000; Full time

Benefits offered by this job

Flexible time off

Tuition reimbursement

401k retirement plan

Work from home anywhere in the US

Maternity/Paternity leave

Casual dress code & work environment

Job summary

Emmes Group is seeking a Sr. In-House CRA to support site management and monitoring of clinical studies, ensuring adherence to protocol, SOPs, and regulatory requirements.

The role includes document maintenance, IRB submissions, and cross-functional coordination with project teams. The candidate should have 2–3 years of clinical research experience, strong MS Office skills, and a science degree, with knowledge of ICH guidelines and quality-oriented attention to detail.

Qualifications

• Bachelor's Degree in a scientific discipline preferred or directly applicable work experience
• 2-3 years of relevant clinical research experience
• Proficient with MS Office Suite
• Excellent computer and organizational skills
• Ability to work independently and cross-functionally with limited oversight
• Knowledgeable in clinical research operations and ICH guidelines
• Strong problem solving and communication skills

Responsibilities

• Assist with site management and monitoring of clinical studies
• Ensure trials are conducted, recorded, and reported per protocol and SOPs
• Maintain essential documents and review for completeness and regulatory compliance
• Submit IRB/EC submissions and track approvals
• Provide trial progress tracking and support junior staff
• Assist in audit preparation and issue resolution
• Coordinate with internal and site staff and manage training and recruitment logs

Skills

MS Office Suite proficiency

Attention to detail

Independent and team player

Strong communication skills

Education

Bachelor's Degree in Scientific discipline

Tools

MS Office Suite

Job description

Sr. In-House CRA

Be Part of One Team, One Purpose.

Overview

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 Senior 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 Sr. In-House CRA may assist in program level status tracking and reporting across multiple studies. The Sr. In-House CRA may also be referred to as a Clinical Trial Associate on some contracts.

Responsibilities

Under the high level supervision of the project site management staff oversight lead (i.e., Clinical Trial Manager, Lead CRA, Clinical Project Manager, etc.)Possesses working 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.).Has solid knowledge of Good Clinical Practices and country regulatory requirements.Independently 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.Performs upload of essential documents into the trial master file.Independently communicates and coordinates effectively with internal project staff members and site staff.Independently completes IRB/EC submissions for sites or submits to central IRB/EC on behalf of the site.Provides project teams with trial progress tracking by updating the Clinical Trial Management System and other software tools.Provides mentorship and training to junior staff on the projectAssists in audit preparation activities as needed.Assists the CRA in Issue and Action Item (AI) resolution post visit and assists with tracking AIs to completion.Tracks site trainingTracks site recruitment efforts and collect/review site screening logs.Assists with the review of the database to assess data currency and may assist site teams with resolving data queries/discrepancies.Reviews site specific language in informed consent forms prior to submission to the IRB/EC.Assists with preparing and independently conducts training and retraining of site staff.Prepares meeting agendas and meeting minutes.May assist in preparing study documents.May assist with ordering clinical trial supplies from vendors such as laboratories and Investigational Product depots.May assist experienced CRA in the conduct of remote and/or on site monitoring visits such as qualification/pre study visits, site initiation visits, interim/routine monitoring visits, closeout visits, and for cause visits.May perform remote review and monitoring of Informed Consent Forms and other source documents.May assist with preparation of DSMB meeting materials.Performs other duties as assignedComplies with all policies and standards

Qualifications

Bachelor's Degree Scientific discipline preferred, or directly applicable work experience preferred Required2-3 years of relevant clinical research experience, (as a CTA, in-house CRA, study coordinator, etc.) RequiredProficient with MS Office Suite HighExcellent computer and organizational skills HighHigh attention to detail required HighAbility to work on varying projects and exercise critical thinking Highself starter who can work independently and a team player who can work cross functionally with limited oversight HighKnowledgeable in clinical research operations, including interpretation and implementation of country specific regulations and ICH guidelines, as required HighExcellent organizational, interpersonal, and communication skills both oral and written HighDemonstrated problem solving skills, self motivated, and adaptable to a dynamic environment HighKnowledgeable in prioritization, problem solving, organization, critical thinking, decision making, time management, and planning activities HighAbility to collaborate with internal and external colleagues and work well in a team oriented setting HighIf 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.

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.

Benefits

• Flexible Approved Time OffTuition Reimbursement401k Retirement PlanWork From Home Anywhere in the USMaternal/Paternal LeaveCasual Dress Code & Work Environment

#LI-Remote

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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One Team, One Purpose.