Clinical Research Associate II

Overview

Clinical Research Associate II

US Remote

Emmes Group : Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Clinical Research Associate (CRA) II 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, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements. The CRA will conduct monitoring visits and activities in accordance with Emmes SOPs, applicable regulations, and ICH GCP.

Responsibilities

• Under supervision of the project CRA staff oversight lead (i.e. 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 study related 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)

(IRB) / Ethics Committee (EC) / Regulatory Authority

recruitment strategies and action plans.

Qualifications

time management, and planning activities

setting.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including :

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The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

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