In-house Clinical Research Associate

Procyrion is seeking an in-house Clinical Research Associate / Senior Clinical Research Associate candidate to support its current and upcoming clinical studies. This position is responsible for managing study sites, collaborating with site monitors, and providing support within all aspects related to clinical affairs. 

Responsibilities

·     Assist with the execution of clinical studies including, but not limited to, liaising with study sites to streamline the contracting, budgeting, and Institutional Review Board (IRB)/Ethics Committee (EC) review/approval process

·     Prepare for and coordinate with monitors to conduct on-site study initiation, interim monitoring and close-out visits at investigative sites to ensure study requirements are being fulfilled 

·     Assist with the development of clinical study documents such as the monitoring, safety management, and document management plans

·     During study conduct;

-manage and oversee the activity at clinical sites

-maintain the Trial Master File to ensure compliance with internal procedures and regulations

-assist with the management of study vendors

-participate in data reviews to ensure study compliance and quality

-prepare documentation for safety reviews and follow-up with monitors/study team and/or clinical sites where needed, to ensure all recommendations/requests for additional information are resolved

·     Participate in the planning and potentially execution of study training meetings (e.g., investigator/coordinator meetings)

·     Perform other clinical duties when requested.

Qualifications

·     Bachelor's Degree in a scientific field or equivalent work experience

·     Minimum of 3 years relevant experience with clinical trial coordination, management and/or clinical operations in medical device, pharma, or CRO (med device strongly preferred)

·     Familiarity with heart failure and/or cardiovascular devices

·     Familiarity with electronic case report forms and data management

·     Excellent written and verbal communication skills in the area of technical/clinical applications

·     High level of comfort interacting with clinicians and other scientific advisors

·     Acknowledgement of and Experience with Good Clinical Practice (GCP)

·     Knowledge of domestic and international regulations concerning the conduct of clinical studies

·     Ability to handle and prioritize multiple assignments simultaneously in a fast-paced work environment with guidance

·     Recognizes the needs and expectations of internal and external customers with guidance from management

·     Effective analytical and problem-solving skills

·     Recognizes and effectively leverages existing relationships

·     Establishes constructive and effective relationships; uses diplomacy and tact

·     Recognizes problems with support and examines potential solutions with guidance

·     Appropriately solicits managerial support during decision making

·     Demonstrates operational execution through task completion and timeline achievements

·     Sets priorities with minimal supervision