Clinical Research Associate II

Emmes Group is a clinical research organization and technology company focused on advancing healthcare through clinical research, data, and analytical solutions. The Clinical Research Associate II monitors clinical study sites remotely and onsite, ensuring trials comply with protocols, SOPs, ICH GCP, and applicable regulations. The role also conducts monitoring visits, documents findings, supports site staff, resolves action items, and collaborates with project teams.

Responsibilities

Under supervision of the project CRA staff oversight lead, example, Clinical Study Manager, Lead CRA, Project Manager, etc., 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

As part of the site visits, independently conducts Informed Consent ICF review, source data verification source document review, review for compliance with required reporting tracking of adverse events 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 minimal direction from the project CRA staff oversight lead

Documents observations and monitoring activities in a site visit report at the conclusion of the visit

Facilitates and oversees Action Item resolution post visit

Helps to ensure that clinical sites are conducting 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 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 studyrelated 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 plan, monitoring documents, etc

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

Assists in preparing sites for audits and may provide support and cooperation during audits inspections including translation to Auditor if needed

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

Preferred

Scientific discipline preferred

Scientific Discipline

Benefits

Opportunities for volunteerism through the Emmes Cares community engagement program

Flexible Approved Time Off

Tuition Reimbursement

401k Retirement Plan

Work From Home Anywhere in the US

Maternal/Paternal Leave

Casual Dress Code & Work Environment

Company

Specialty CRO providing clinical trial services and technology solutions

Rockville, Maryland, USA

https://theemmesgroup.com/

Founded in 1977

1001-5000 employees

Qualifications

Bachelor's Degree Scientific discipline

equivalent work experience

1-3 years 1-2 years of relevant monitoring experience (on-site and remote)

Proficient with MS Office Suite

Excellent computer and organizational skills

High level of attention to detail required

Ability to work on varying projects and exercise critical thinking

self starter who can work remotely and a team player who can work cross functionally with some oversight

Knowledgeable in clinical research operations, including interpretation and implementation of country regulations and ICH guidelines, as required per their role as a CRA

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, decisionmaking, time management, and planning activities

Ability to collaborate with internal and external colleagues and work well in a team oriented setting

Equivalent work experience

Self starter who can work remotely and a team player who can work cross functionally with some oversight

Scientific discipline preferred

Required skills

Clinical Trial Monitoring, Clinical Research Operations, ICH Good Clinical Practice (GCP), Country-Specific Clinical Research Regulations, Microsoft Office Suite

Preferred skills

Scientific discipline preferred

Experience

1-3 years