Clinical Research Associate

Are you an experienced Clinical Research Associate seeking to be a pivotal part of launching Clinical Trials in the US for an organization that is developing a breakthrough medical device that can save lives If so this job may be for you!

Aria CV founded in 2010 is developing a novel implantable medical device in pulmonary hypertension. Aria has performed a successful acute first in human clinical study in Vienna Austria and is now preparing for a U.S. clinical trial under FDAs Early Feasibility Study Program to evaluate the safety and efficacy of long-term implants in PAH patients. This exciting time has yielded a need for a Sr. Clinical Research Associate.

Reporting to the Director of Clinical Research the Sr. Clinical Research Associate provides Study execution support for Aria CV Clinical studies. This includes site management activities developing study related documents conducting monitoring visits training coordinators on protocol and assisting with data management activities.

This is a unique opportunity to work in a highly scientific start-up organization that puts patient care at the forefront of all interactions. The team at Aria CV are highly engaged and have a deep respect for each others expertise. The top leaders and board members have a proven track record of success.

Aria CV won the Transcatheter Cardiovascular Therapeutics 2018 Shark Tank Competition and was named in the MedTech Innovators 2021 Top 50 Showcase companies a highly competitive distinction.

If you are seeking to join a team of professionals who care deeply about what they do highly regard team members contributions and are constantly striving for excellence in patient care then Aria CV may be the company for you!

Essential Duties and Responsibilities:

• Perform site management activities to ensure compliance with GCP and FDA regulations for clinical trials
• Support clinical trials in collaboration with other clinical team members pertaining to site qualification initiation and ongoing site support for clinical trials
• Develop study related documents including case report forms study manuals and other study related tools
• Assists in data management activities including query generation and resolution
• Reviews site-specific informed consent forms and site activation documentation
• Assists in planning and preparing materials for investigator and coordinator meetings
• Assists with reporting study metrics e.g. subject screening and enrollment data collection documentation of adverse events
• Assists with preparation of study summary reports for presentations publications and regulatory submissions
• Provides input to the data management plan monitoring plan safety plan and communication plan
• Conducts monitoring visits to study sites including qualification initiation routine (as needed to ensure protocol compliance) and close-out visits
• Trains study coordinators/investigators on protocol including study procedures CRF completion enrollment and informed consent
• Supports site research coordinators with protocol compliance and EDC navigation/data entry
• Works with site research coordinators to resolve data discrepancies
• Obtains/reviews/processes regulatory and administrative documents from investigative sites
• Maintains investigational product accountability
• Has technical knowledge of product
• Travel is approximately 10 - 30% to investigative sites and meetings
• Travel to international sites may be required

Qualifications:

• Bachelors degree preferably in a medical/scientific field
• 4 years experience supporting clinical research or similar experience in a medical and/or scientific area
• Masters degree will substitute for 1 year of experience
• Clear in-depth knowledge and proficient in FDA regulations and ICH/GCP guidelines
• Demonstrated ability to anticipate and meet deadlines prioritize work strong attention to detail and the ability to retain confidential information
• Proficiency in MS Office including PowerPoint Excel and Word
• Must be customer service oriented with strong interpersonal skills
• A reputation for excellent organizational skills
• A solid track record of being responsive action-oriented and a problem solver

About Talencio

Talencio provides executive search services dedicated to medical device biotech and pharmaceutical companies. Over the past 13 years we have delivered the right people at the right time to drive growth initiatives for companies dedicated to being catalysts for life sustaining products.

Qualified candidates please send resumes to

No recruiters please.