Senior Associate, Clinical Research

Overview

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 regulatory requirements. The ideal candidate will have a thorough knowledge of Good Clinical Practices (GCP) and applicable regulations.

• 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 Jena Valve procedures is current.
• Conduct periodic audits of internal files to ensure compliance per site IRB and/or Ethics Committee 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.

Required Education And Experience

• 2+ year of experience in clinical trial research is required (preferred in medical devices).
• Advanced degree in a biological science / pharmacy/ nursing desired.

Skills And Abilities Required For This Job

• 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, ISO
  14155 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.