Clinical Research Monitoring (CRA)

Clinical Research Associate II
Emmes Group is a full-service contract research organization (CRO) that modernises clinical trials and accelerates the development of life-changing therapies. With 47 years of scientific excellence, the company focuses on cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases and neuroscience.

Responsibilities

Schedule and conduct remote and onsite monitoring visits including qualification, site initiation, interim routine, close-out and for-cause visits.

Conduct Informed Consent review, source data verification, adverse event tracking, protocol deviation review, investigator site file review and other activities defined in the site monitoring plan.

Document observations and monitoring activities in a site visit report and facilitate action-item resolution post-visit.

Ensure sites conduct the study in compliance with the protocol, SOPs, ICH GCP and applicable regulations.

Provide training and re-training to site staff on protocol, GCP and other requirements.

Identify areas requiring follow-up and improvement and report findings to the project CRA staff oversight lead.

Serve as the point of contact for study site personnel to resolve study-related issues.

Assist with development and review of study-related materials such as protocols, informed consent forms and monitoring plans.

Prepare for and attend project team meetings and provide updates on project status and site performance.

Work collaboratively in a project-team environment with internal and external colleagues to meet objectives and timelines.

Participate in investigator meetings and other client meetings as needed.

Assist with filing and archiving of study documents and with preparations for audits and inspections.

Assist with coordination of clinical study supplies.

Assist with submission of applications and notifications to Institutional Review Board (IRB) / Ethics Committee (EC) / Regulatory Authority.

Assist with site recruitment oversight activities, including developing patient recruitment strategies and action plans.

Perform site management activities as required.

Perform other duties as assigned.

Comply with all policies and standards.

Qualifications

Bachelor’s degree in a scientific discipline or equivalent experience.

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

Proficiency with MS Office Suite.

Excellent computer, organisational and time-management skills.

High attention to detail.

Strong critical thinking and problem-solving ability.

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 of country regulations and ICH guidelines.

Excellent organisational, interpersonal and written and oral communication skills.

Demonstrated adaptability to a dynamic environment.

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

#J-18808-Ljbffr Emmes Group