Sr. Clinical Research Associate

Emmes Group•Rockville, MD

15h

About The Position

The Senior Clinical Research Associate (CRA) monitors clinical study sites remotely and on-site to help ensure trials are conducted, recorded, and reported in accordance with study protocols, standard operating procedures (SOPs), ICH GCP, and applicable regulatory requirements. The role conducts monitoring activities and visits in accordance with Emmes SOPs, applicable regulations, and ICH GCP. The position is listed as US remote and on-site, with 80% travel. Working under minimal supervision from project CRA staff oversight leads, the Senior CRA independently conducts site monitoring, documents findings, follows up on action items, supports site compliance and staff training, and collaborates with project teams and study stakeholders. The role may also contribute to study materials, site preparation for audits, document filing and archiving, clinical supply coordination, regulatory submissions, and site recruitment oversight.

Requirements

Bachelor’s degree in a scientific discipline or equivalent work experience.
4–6 years of on-site and remote monitoring experience.
Proficiency with the MS Office Suite.
Excellent computer and organizational skills.
Exceptional attention to detail.
Ability to work across varying projects and apply critical thinking with minimal oversight.
Self-starter able to work remotely and collaborate cross-functionally as a team player with minimal oversight.
Expertise in clinical research operations, including interpretation and implementation of country regulations and ICH guidelines relevant to the CRA role.
Excellent oral and written organizational, interpersonal, and communication skills.
Demonstrated problem-solving skills; self-motivation; and adaptability to a dynamic environment.
Expertise in prioritization, problem solving, organization, critical thinking, decision making, time management, and planning.
Ability to collaborate with internal and external colleagues and work effectively in a team-oriented setting.

Responsibilities

Independently schedule and conduct remote and on-site qualification/pre-study, site initiation, interim/routine monitoring, closeout, and for-cause visits under minimal supervision.
Conduct monitoring activities including informed consent review, source data verification and source document review, adverse event and protocol deviation reporting/tracking review, investigator site file review, laboratory and specimen storage assessment, investigational product/device storage and accountability assessment, and facilities tours.
Document observations and monitoring activities in site visit reports with minimal feedback from the report reviewer.
Facilitate and oversee resolution of post-visit action items.
Help ensure clinical sites conduct studies in compliance with protocols or clinical investigational plans, SOPs, ICH GCP, and applicable regulations.
Provide training and retraining to site staff on protocols, GCP/GDP, and other topics under direction of the project CRA staff oversight lead.
Identify site follow-up and improvement needs and report findings to the project CRA staff oversight lead.
Ensure visits comply with country regulations, ICH GCP, and company SOPs.
Serve as a point of contact for site personnel, answering questions and resolving study-related issues under direction of the project CRA staff oversight lead.
May assist with developing or reviewing study materials, including protocols, informed consent forms, monitoring plans, and monitoring documents.
Prepare for and attend project team meetings and provide updates on project status and site performance.
Collaborate with internal and external colleagues to meet project objectives and timelines.
Participate in Investigator Meetings and other client meetings as needed.
Assist with filing and archiving study documents.
Assist in preparing sites for audits and support audits or inspections, including translation for an auditor if needed.
May assist with coordination of clinical study supplies.
May assist with submissions of applications or notifications to IRBs, Ethics Committees, or Regulatory Authorities.
May assist with site recruitment oversight, including focused patient recruitment strategies and action plans.
Perform site management activities as required, other assigned duties, and comply with all policies and standards.