Sr. Clinical Research Associate

Getinge•Boston, MA

1d•$110,000 - $125,000•Hybrid

About The Position

Paragonix Technologies develops and markets organ transportation and preservation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time. The Senior Clinical Research Associate is responsible for oversight of the prospective randomized clinical studies conducted by Paragonix Technologies. This position is responsible for managing studies across solid organ platforms. The Senior Clinical Research Associate will report to the VP Scientific and Medical Affairs and will play an important role in study data management and overall clinical operations of the prospective randomized studies.

Requirements

Minimum requirement of a Bachelor's Degree, preferably in health sciences or a related field
Minimum of 6+ years of clinical research associate experience, in particular in supporting randomized clinical trials in either the medical device or pharmaceutical industry is required.
Experience with data collection and project management tools.
Critical attention to detail and accuracy.
Ability to communicate appropriately and effectively both orally and in writing.

Nice To Haves

Experience in cardiothoracic clinical trials preferred.

Responsibilities

Provides data coordination and data management for randomized clinical studies.
Manages investigative site activity for multiple protocols.
Coordinates budgets and invoicing
Creates and implements subject enrollment strategies for assigned investigative sites.
Ensures clinical trials are managed and executed following ICH GCP, regulations, the protocol, and company-specific SOPs.
Designs CRFs and eCRFs for data acquisition and data entry.
Works closely with sites to train and support data capture and cleaning, coordinating efficient corrections to the database, assisting with troubleshooting and site challenges.
Defining necessary validations or reports to ensure quality and timeliness of data collection.
Monitoring study metrics and site performance using standard study management tools.
Collaborates with the study team to prepare abstracts, manuscripts, and other materials for internal and external audiences.
Participates in meetings with multidisciplinary teams both internally and externally to ensure successful and timely completion of deliverables.
Supports reporting to clinicaltrials.gov including data review, quality control checks, and interim and final analysis.
Ability to understand the objectives of a study and ensure that the databases, study case report forms, and data analysis match the overall study goals.