Sr. In-House CRA

About the role

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.

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

• Assist with operational activities supporting site management and monitoring of clinical studies/trials under high-level supervision of project site management staff oversight lead (e.g., Clinical Trial Manager, Lead CRA, Clinical Project Manager).
• Possess 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).
• Maintain solid knowledge of Good Clinical Practices and country regulatory requirements.
• Independently collect, review, maintain, and track required essential documents, including assessment of completeness, accuracy, and compliance with good documentation practices and regulatory/local requirements.
• Perform upload of essential documents into the trial master file.
• Independently communicate and coordinate effectively with internal project staff members and site staff.
• Independently complete IRB/EC submissions for sites or submit to central IRB/EC on behalf of the site.
• Provide project teams with trial progress tracking by updating the Clinical Trial Management System and other software tools.
• Provide mentorship and training to junior staff on the project.
• Assist in audit preparation activities as needed.
• Assist the CRA in Issue and Action Item (AI) resolution post visit and assist with tracking AIs to completion.
• Track site training.
• Track site recruitment efforts and collect/review site screening logs.
• Assist with the review of the database to assess data currency and may assist site teams with resolving data queries/discrepancies.
• Review site-specific language in informed consent forms prior to submission to the IRB/EC.
• Assist with preparing and independently conduct training and retraining of site staff.
• Prepare 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.
• Perform other duties as assigned.
• Comply with all policies and standards.

Qualifications

• Bachelor’s degree in a scientific discipline preferred, or directly applicable work experience preferred.
• 1–3 years of relevant clinical research experience (as a CTA, in-house CRA, study coordinator, etc.).
• Proficient with MS Office Suite.
• Excellent computer and organizational skills.
• High attention to detail.
• Ability to work on varying projects and exercise critical thinking.
• Self-starter who can work independently and a team player who can work cross-functionally with limited oversight.
• Knowledgeable in clinical research operations, including interpretation and implementation of country-specific regulations and ICH guidelines.
• Excellent organizational, interpersonal, and communication skills, both oral and written.
• Demonstrated problem-solving skills, self-motivated, and adaptable to a dynamic environment.
• Knowledgeable in prioritization, problem solving, organization, critical thinking, decision making, time management, and planning activities.
• Ability to collaborate with internal and external colleagues and work well in a team-oriented setting.

Benefits

• Flexible Approved Time Off
• Tuition Reimbursement
• 401k Retirement Plan
• Work From Home Anywhere in the US
• Maternal/Paternal Leave
• Casual Dress Code & Work Environment