Clinical Research Associate (remote)

Company: Bongene Search
Location: Portland
Posted on: January 10, 2022

Job Description:

Bongene Search is biotech, pharmaceutical, and medical staffing agency that believes talent lies at the heart of all great companies. As such, the team at Bongene Search is dedicated to helping our clients around the globe create the most talented team of biopharma professionals. Whether it is a large publicly-traded company or a biotech start-up, our medical, pharmaceutical, and biotech recruiting agency will create a tailor-made search process that delivers the perfect fit for the role. We represent the following opportunity from our client.

Clinical Research Associate

RESPONSIBILITIES

Lead small groups, interact well with teams yet also be independent contributors
Deal with conflicts and resolutions, representing the company externally
Take responsibility for a number of studies/sites and provide updates to the management
Understand the company's products (cartridges/samples/analyzers)
Understand preanalytical sample handling issues and be able to run various cartridges
Support the creation of the protocol and all of the associated study documentation (brochures, ICFs, CRFs, IRB submission packages, etc)
Identify and prequalify/approve sites where the studies will be carried out
Support the creation of study-specific electronic data collection fields and system elements (additionally be able to do user acceptance testing)
Support the creation of the clinical trial master file folders and system elements
Work with sites to ensure all of the documentation from sites is collected prior to starting the study and is also filed
Support preparation and execution for study site initiations, collecting documents, generating training modules
Understand and be able to carry out data/site monitoring both remotely and onsite
Support data verification and reviews to prepare collected data for analyses
Lead and work with sites for closeout of the studies
Lead and carry out post-study tasks regarding reports, trial master file documents, financial documentation, etc.
Be very organized and comfortable carrying out clinical study tasks remotely and on-site

QUALIFICATIONS

3-6 years relevant work experience
Bachelor's degree or equivalent experience required; prefer a background in the sciences or a medically-related area
Broad knowledge and application of business concepts, procedures, and practices
Knowledge of Good Manufacturing Practice 21 CFR Part 820; International Harmonized /Committee Good Clinical Practices, IHC/GCP
Basic computer software like MS Office (Word, Excel, and PowerPoint) as well as Lotus Notes

Keywords: Bongene Search, Portland , Clinical Research Associate (remote), Healthcare , Portland, Maine