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 stive 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) I 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 the supervision of the project CRA staff oversight lead (i.e. Clinical Study Manager, Lead CRA, Project Manager, etc.), 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, 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 direction from the project CRA staff oversight lead

• Documents observations and monitoring activities in a site visit report at the conclusion of the visit with assistance and oversight by the project CRA staff oversight lead

• 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

• May assist with the development and/or review of study-related materials including protocols, informed consent forms, monitoring plan, monitoring documents, etc.

• Participates in Investigator Meetings or other client meetings as needed

• Performs site management activities as required

• Other duties as assigned

Qualifications

• Master´s degree (scientific discipline preferred)

• 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 independently and a team player who can work cross functionally with heavy oversight

• 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, decision making, time management, and planning activities

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