Senior Associate, Clinical Research

JENAVALVE TECHNOLOGY INC•Irvine, CA

5d•$95,000 - $95,000•Onsite

About The Position

The Senior Clinical Research Associate will report to the Director, Clinical Affairs, and will play a key role in proactively supporting the conduct of pre-market clinical studies and ensure compliance with all regulatory requirements. The ideal candidate will have a thorough knowledge of Good Clinical Practices (GCP) and applicable regulations.

Requirements

2+ year of experience in clinical trial research is required (preferred in medical devices).
Advanced degree in a biological science / pharmacy/ nursing desired.
Proficient in clinical trial management and electronic data capture systems to document and record information.
Excellent communication skills (written and verbal English) so as to be able to build effective relationships with trial center staff and colleagues.
Deep knowledge of GCPs governing the conduct of clinical trials; working knowledge of Medical Device Directive 93/42/EEC, ISO14155 and ICH guidelines.
Very organized and able to pay close attention to detail.
Team player with a willingness to help where needed and work with diverse people.
Ability to travel up to 20% time.

Responsibilities

Support site management and interact with site coordinators, investigators, and field monitors in collecting data and resolving queries to meet the protocol requirements in a timely manner.
Ensure quality data management activities – i.e., data review, query generation and resolution.
Generate status reports to clinical staff and management.
Generate queries to resolve data issues and apply corrections to database.
Act as a point person for all data related to clinical group, and to provide data to cross-functional departments.
Conduct EDC training to external teams and sites.
Maintain Trial Master Files and trackers for clinical trials.
Manage trial-related regulatory documents and provide follow-up action listings to ensure that all clinical documentation required by regulations and JenaValve procedures is current.
Conduct periodic audits of internal files to ensure compliance per site Institutional Review Board (IRB) and/or Ethics Committee (EC) policy (i.e. IRB continuing review approval period and expiration dates).
Provide clinical operational support during preparation for and conduct of all clinical audits and inspections.
Contribute to the development and implementation of departmental policies, standards, and process improvement initiatives.
Partner with management to manage external vendors, including ongoing supplier qualification.
Assist field clinical monitors in preparation for site training and monitoring visits
Support co-monitoring of local sites on an as-needed basis.