Sr. Clinical Research Associate

Emmes Group; Rockville (MD); Hybrid; USD 70,000 - 90,000; Full time

Job summary

Emmes Group in Rockville, Maryland is seeking a Senior Clinical Research Associate to oversee monitoring of clinical study sites, ensuring compliance with regulatory requirements and protocols. This role involves conducting both remote and on-site visits, documenting findings, and facilitating training.

The ideal candidate will possess a Bachelor's Degree in a scientific discipline, along with 4-6 years of monitoring experience. Excellent organizational skills and attention to detail are essential in this dynamic environment.

Qualifications

• 4-6 years of clinical monitoring experience, both remote and on-site.
• Expertise in clinical research operations and regulations.
• Ability to work as a self-starter and team player within various projects.

Responsibilities

• Conduct remote and on-site monitoring visits with minimal supervision.
• Ensure compliance with protocols, SOPs, and regulations.
• Document observations in reports and facilitate action-item resolution.

Skills

Monitoring experience

MS Office Suite proficiency

Attention to detail

Organizational skills

Problem-solving skills

Interpersonal skills

Education

Bachelor’s Degree in a scientific discipline or equivalent work experience

Job description

Senior Clinical Research Associate

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 Clinical Research Associate (CRA) 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, SOPs, ICH GCP, and all applicable regulatory requirements.

Responsibilities

• Independently schedules and 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, with minimal supervision.
• Conducts ICFA review, source data verification, recommendation of reporting/tracking of adverse events and protocol deviations, investigator site file review, laboratory tour, specimen storage assessment, pharmacy/IPP/IP/ID storage condition assessment, IP/ID accountability, facilities tours, and other activities per the site monitoring plan.
• Documents observations and monitoring activities in a site visit report at the conclusion of the visit.
• Facilitates and oversees action‑item resolution post‑visit.
• Ensures clinical sites comply with the protocol, SOPs, ICH GCP, and applicable regulations.
• Provides training and retraining to site staff on protocol, GCP/GDP, and other training.
• Identifies areas requiring follow‑up and improvement at each site and reports findings.
• Serves as point of contact for study site personnel to resolve study‑related issues.
• May assist with development or review of study‑related materials including protocols, informed consent forms, monitoring plan, monitoring documents, etc.
• Prepares for and attends project team meetings and provides updates on project status and site performance.
• Works collaboratively and effectively in a project team environment.
• Participates in investigator meetings or other client meetings as needed.
• Assists with filing and archiving of study documents.
• Assists in preparing sites for audits and may provide support and cooperation during audits/inspections.
• Assists with coordination of clinical study supplies.
• Assists with submission of applications/notifications to IRB/EC/ regulatory authority.
• Assists 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.

Qualifications

• Bachelor’s Degree in a scientific discipline or equivalent work experience.
• 4–6 years of monitoring experience (on‑site and remote).
• Proficient with MS Office Suite.
• Excellent computer and organizational skills.
• Exceptional attention to detail.
• Ability to work on varying projects and exercise critical thinking with minimal oversight.
• Self‑starter who can work remotely and is a team player.
• Expertise in clinical research operations, including interpretation and implementation of country regulations and ICH guidelines.
• Excellent organizational, interpersonal, and communication skills.
• Demonstrated problem‑solving skills, self‑motivated, and adaptable to a dynamic environment.
• Expertise in prioritization, organization, critical thinking, decision making, time management, and planning.
• Ability to collaborate with internal and external colleagues and work well in a team‑oriented setting.

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