JenaValve Technology, Inc. · 4 days ago
Senior Associate, Clinical Research
Irvine, CA
Full-time
Hybrid
Mid, Senior Level
2+ years expJenaValve Technology, Inc. is seeking a Senior Associate, Clinical Research to support the conduct of pre-market clinical studies and ensure compliance with regulatory requirements. The role involves managing site interactions, data quality, and regulatory documentation while contributing to departmental policies and process improvements.
Health CareManufacturingMedical Device
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
Qualification
Required
2+ year of experience in clinical trial research is required (preferred in medical devices)
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
Preferred
Advanced degree in a biological science / pharmacy/ nursing desired
Company
JenaValve Technology, Inc.
JenaValve is a medical device company developing the first transcatheter heart valve technology that is uniquely designed for the minimally invasive treatment of aortic regurgitation (AR).
51-200 employees
H1B Sponsorship
JenaValve Technology, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (3)
2021 (4)
Funding
Current Stage
Growth StageTotal Funding
$341.57MKey Investors
Bain Capital Life SciencesRMMFraunhofer Venture
2024-07-24Acquired
2022-08-31Series C· $100M
2022-01-04Series Unknown· $8M
Leadership Team
John Kilcoyne
CEO
Kari-Lyn Moore
Chief Financial Officer
Recent News
JenaValve Technology, Inc.
2025-11-24
2025-11-14
Company data provided by crunchbase