Clinical Research Associate I

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 Clinical Research Associate (CRA) I is responsible for monitoring clinical study sites either on-site at investigative sites or remotely to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements.

Responsibilities

• Under the supervision of the project CRA staff oversight lead (e.g., Clinical Study Manager, Lead CRA, Project Manager), conducts remote and on-site monitoring visits such as qualification/pre-study visits, site initiation visits, interim routine monitoring visits, closeout visits, and for-cause visits.
• As part of site visits, conducts Informed Consent (ICF) review, source data verification/source document review, compliance review for adverse event reporting and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy/Investigational Product (IP)/Investigational Device (ID) storage location tour and storage condition assessment, IP/ID accountability, facilities tours, and other activities per the site monitoring plan under direction from the project CRA staff oversight lead.
• Documents observations and monitoring activities in a site visit report at the conclusion of the visit with assistance and oversight by the project CRA staff oversight lead.
• Facilitates and oversees Action Item resolution post-visit.
• Helps ensure clinical sites conduct the study in compliance with protocol, clinical investigational plan, SOPs, ICH GCP, and other applicable regulations.
• Provides training and retraining to site staff, including protocol, GCP, GDP, and other training under direction from the project CRA staff oversight lead.
• Identifies areas requiring follow-up and improvement at each clinical study site and reports findings to the project CRA staff oversight lead.
• Ensures all visits are conducted according to country regulations, ICH GCP, and company standard operating procedures.
• Serves as point of contact for study site personnel to answer questions and resolve study-related issues under the direction of the project CRA staff oversight lead.
• May assist with the development and/or review of study-related materials including protocols, informed consent forms, monitoring plans, and monitoring documents.
• Prepares for and attends project team meetings and provides updates on project status and site-specific performance.
• Works collaboratively and effectively in a project team environment, including internal and external colleagues, to meet project objectives and timelines.
• Participates in Investigator Meetings or other client meetings as needed.
• Assists with filing and archiving of study documents.
• May assist with coordination of clinical study supplies.
• May assist with submission of applications/notifications to Institutional Review Board (IRB)/Ethics Committee (EC)/Regulatory Authority.
• May assist with site recruitment oversight activities, such as developing focused patient recruitment strategies and action plans.
• Performs site management activities as required.
• Performs other duties as assigned.
• Complies with all policies and standards.

Requirements

• Bachelor’s Degree (scientific discipline preferred) or equivalent work experience.
• 1–3 years of professional experience (1 year preferred).
• Prior clinical research experience (as a CTA, in-house CRA, CRC, etc.) preferred.
• Proficient with MS Office Suite.
• Excellent computer and organizational skills.
• High level of attention to detail.
• Ability to work on varying projects and exercise critical thinking.
• Self-starter who can work remotely/independently and as a team player in a cross-functional environment with heavy oversight.
• Knowledgeable in clinical research operations, including interpretation and implementation of country regulations and ICH guidelines.
• Excellent organizational, interpersonal, and communication skills (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

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in local communities, with opportunities for volunteerism through our Emmes Cares community engagement program.