Job Title: Coordinator, Clinical Affairs
Supervisor/Manager Title: Director, Clinical Affairs
Job Description Summary: Supports Clinical Research Associates (CRAs) to manage specific activities related to clinical projects.
Job Responsibilities:- Participate in site start-up, maintenance, and close-out activities (e.g. tracking site progress, creating regulatory and subject binders, investigate discrepancies, etc.)
- Provides support to CRAs who are conducting site visits, as needed.
- Serves as quality control for study-related documents and is accountable for content accuracy to ensure compliance with GDP, US and OUS regulations, and internal company procedures
- Maintains organization, preparation and ordering of supplies required for clinical studies.
- Provides support to CRAs for preparing documentation, reports, and presentations.
- Coordinates study-related meetings, as needed.
- Minute taker and distributor
- Other incidental duties
- Requires a Bachelor’s degree in related field
- High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently.
- Good computer skills in usage of MS Office Suite
- Strict attention to detail
- Good written and verbal communication skills
- Must be able to work in a team environment
- Adhere to all company rules and requirements
Skills Required
- Bachelor's degree in related field
- High level of personal and professional integrity and trustworthiness with strong work ethic and ability to work independently
- Good computer skills in usage of MS Office Suite
- Strict attention to detail
- Good written and verbal communication skills
- Must be able to work in a team environment
- Adhere to all company rules and requirements
What We Do
JenaValve Technology, Inc., with locations in Irvine, Calif., Leeds, U.K. and Munich, Germany, develops and manufactures transcatheter aortic valve replacement (TAVR) systems to treat patients suffering from aortic valve disease. The Company is in clinical development of its next-generation transfemoral TAVR system in both the U.S. and CE mark countries for treating patients with aortic stenosis and/or aortic regurgitation. In addition to Bain Capital Life Sciences, JenaValve is backed by European and Asian investors, including Andera Partners (formerly Edmond de Rothschild Investment Partners), Gimv (Euronext: GIMB), Legend Capital, NeoMed Management, RMM, Valiance Life Sciences and VI Partners. Additional information is available at www.jenavalve.com.
