Senior Associate, Clinical Research
JENAVALVE TECHNOLOGY INC·Irvine, California
JENAVALVE TECHNOLOGY INC·Irvine, California
The Senior Clinical Research Associate will support the conduct of pre-market clinical studies, ensuring compliance with regulatory requirements, and will manage data collection, query resolution, and status reporting for clinical staff and management. Responsibilities also include conducting EDC training, maintaining Trial Master Files, managing regulatory documents, and supporting clinical audits.
Summary: 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. Job 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. QualificationsRequired 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, 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. Physical Requirements: Ability to travel up to 20% time.
Candidates must have at least 2 years of experience in clinical trial research, preferably in medical devices, and possess a thorough knowledge of Good Clinical Practices (GCP) and related guidelines. Required abilities include proficiency in clinical trial management systems, excellent communication skills, high organization, and attention to detail.
Market context
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Associate, Clinical Research
Associate, Clinical Research