Sr. Clinical Research Associate

Emmes•Rockville, WA

About The Position

The Senior Clinical Research Associate (CRA) monitors clinical study sites remotely and on-site to ensure clinical trials are conducted, recorded, and reported in accordance with study protocols, standard operating procedures (SOPs), ICH Good Clinical Practice (GCP), and applicable regulatory requirements. The role conducts monitoring activities in accordance with Emmes SOPs, applicable regulations, and ICH GCP, with 80% travel. Under minimal supervision of a project CRA staff oversight lead, the CRA independently schedules and conducts qualification/pre-study, site initiation, interim/routine monitoring, closeout, and for-cause visits. The CRA reviews informed consent, source data and documents, adverse event and protocol deviation reporting, investigator site files, laboratory and specimen storage, investigational product/device storage and accountability, and site facilities. The CRA documents findings, follows up on action items, trains site staff, supports study teams and sites, and may assist with study materials, audits, supplies, regulatory submissions, recruitment oversight, and study document filing and archiving.

Requirements

Bachelor's degree in a scientific discipline or equivalent work experience.
4–6 years of monitoring experience, both on-site and remotely.
Proficiency with the Microsoft Office Suite.
Excellent computer and organizational skills and exceptional attention to detail.
Ability to work across varying projects, think critically, and operate with minimal oversight.
Self-starter able to work remotely and collaborate cross-functionally with minimal oversight.
Expertise in clinical research operations, including interpreting and implementing applicable country regulations and ICH guidelines.
Excellent organizational, interpersonal, oral, and written communication skills.
Demonstrated problem-solving skills; self-motivated and adaptable 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 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.
Conduct informed consent review, source data verification and source document review, and review adverse event and protocol deviation reporting and tracking.
Review investigator site files and assess laboratories, specimen storage, investigational product/device storage conditions and accountability, and site facilities.
Document monitoring activities and observations in site visit reports and facilitate resolution of post-visit action items.
Help ensure clinical sites comply with the protocol or clinical investigational plan, SOPs, ICH GCP, and applicable regulations.
Provide training and retraining to site staff on protocols, GCP/GDP, and other topics under the direction of the project CRA staff oversight lead.
Identify site issues and improvement needs, report findings to the project CRA staff oversight lead, and serve as a contact for site personnel to address study-related questions and issues.
Conduct visits in accordance with country regulations, ICH GCP, and company SOPs.
May assist in developing or reviewing study materials, including protocols, informed consent forms, monitoring plans, and monitoring documents.
Prepare for and attend project team meetings, provide updates on project status and site performance, and participate in investigator or client meetings as needed.
Work collaboratively with internal and external colleagues to meet project objectives and timelines.
Assist with filing and archiving study documents and preparing sites for audits; support audits and inspections, including translation for auditors if needed.
May assist with coordination of clinical study supplies and submissions 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 and other assigned duties; comply with company policies and standards.