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In-House Clinical Research Associate

Remote:

Full Remote

Contract:

Full time

Experience:

Entry-level / graduate

Work from:

Czechia

Offer summary

Qualifications:

Bachelor’s degree or relevant experience, Proficient in MS Office, detail-oriented.

Key responsabilities:

Support site management and monitoring activities
Maintain essential documents, assist with ICFs

Emmes Research Large https://www.emmes.com/

1001 - 5000 Employees

See more Emmes offers

Job description

Overview

In-House Clinical Research Associate

Czech Republic - Prague

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 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 In-House Clinical Research Associate (CRA) is responsible for assisting with operational activities supporting the site management and monitoring of clinical studies/trials, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and all applicable regulatory requirements. The In-House CRA may also be referred to as a Clinical Trial Associate on some contracts.

Responsibilities

Under the supervision of the project site management staff oversight lead (i.e., Clinical Trial Manager, Lead CRA, Clinical Project Manager, etc.)
Possesses basic knowledge of the study protocol, site monitoring plan, and study manuals to triage questions or requests from site staff (e.g., enrollment updates, questions, missing documentation, meeting arrangements, etc.).
Knowledge of Good Clinical Practices and country regulatory requirements.
Collects, reviews, maintains, and tracks required essential documents. Review includes assessment of completeness, accuracy, and compliance with good documentation practices and regulatory and local requirements.
Performs upload of essential documents into the trial master file.
Communicates and coordinates effectively with internal project staff members and site staff.
Completes IRB/EC submissions for sites or submits to central IRB/EC on behalf of the site.
Assists project teams with trial progress tracking by updating the Clinical Trial Management System and other software tools.
Assists in audit preparation activities as needed.
Assists the CRA in Issue and Action Item (AI) resolution post visit and assists with tracking AIs to completion.
Reviews site-specific language in informed consent forms prior to submission to the IRB/EC.
Tracks site training
May assist with feasibility and site activation processes in collaboration with clinical operations counterparts.
May assist in preparing study documents.
May assist with ordering clinical trial supplies from vendors such as laboratories and Investigational Product depots.
May track site recruitment efforts and collect/review site screening logs.
May assist with the review of the database to assess data currency and may assist site teams with resolving data queries/discrepancies.
May assist with preparing or conducting training and retraining of site staff
May assist on-site CRA in the conduct of remote and/or on-site monitoring visits such as qualification/pre-study visits, site initiation visits, interim/routine monitoring visits, closeout visits, and for-cause visits.
May perform remote review and monitoring of Informed Consent Forms and other source documents
Other duties as assigned.

Qualifications

Bachelor’s degree (scientific discipline preferred) or directly applicable work experience preferred
Previous clinical research experience preferred (as a CTA, in-house CRA, study coordinator, etc.)
Proficient with MS Office Suite
Excellent computer and organizational skills
High attention to detail required
Ability to work on varying projects and exercise critical thinking
Self-starter and a team player who can work cross functionally with limited 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

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